A Phase 3 Study of Tanezumab for Chronic Low Back Pain

Low Back Pain Clinical Trial

— TANGO  

Official title:

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE‑CONTROLLED, MULTICENTER, PARALLEL‑GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528253
• Other study ID #: A4091059
• Secondary ID: 2012-005495-34CL
• Status: Completed
• Phase: Phase 3
• Start date: August 18, 2015
• Est. completion date: December 20, 2018

Study information

• Verified date: February 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

Description:

This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1832
• Est. completion date: December 20, 2018
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Chronic low back pain =3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.

Exclusion Criteria:

--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.

• Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;

• History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).

• History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.

• Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study

• History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol

• Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Biological:
• Placebo to Week 16; tanezumab 5mg SC
Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
• Placebo to Week 16, tanezumab 10 mg SC
Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
• Tanezumab 5 mg SC
Tanezumab 5 mg SC
• Tanezumab 10 mg SC
Tanezumab 10 mg SC
• Tramadol PR oral
Tramadol PR oral

Locations

Country	Name	City	State
Canada	SKDS Research Inc.	Newmarket	Ontario
Canada	Centre de recherche Saint-Louis	Quebec
Canada	G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.	Quebec
Canada	London Road Diagnostic Clinic & Medical Centre	Sarnia	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Denmark	A2 reumatologi og idraesmedicin ApS	Hillerod
France	Hopital Cochin	Paris Cedex 14
Hungary	Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz	Bekescsaba
Hungary	Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.	Budapest
Hungary	Obudai Egeszsegugyi Centrum Ktf.	Budapest
Hungary	Jutrix Kft.	Kecskemét
Hungary	CRU Hungary Ltd., MISEK HOSPITAL	Miskolc
Hungary	CRU Hungary Ltd., MISEK-Radiology Department	Miskolc
Hungary	Clinfan Kft.	Szekszard
Hungary	Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly	Szekszard
Japan	Fukushima Medical University Aizu Medical Center	Aizuwakamatsu	Fukushima
Japan	National Hospital Organization Beppu Medical Center	Beppu	Oita
Japan	Tokyo Medical and Dental University Medical Hospital	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital	Chuo-ku, Chiba	Chiba
Japan	Chihaya Hospital	Fukuoka
Japan	Kuroda Orthopedic Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Funabashi Municipal Medical Center	Funabashi	Chiba
Japan	Fussa Hospital	Fussa	Tokyo
Japan	Hakodate Central General Hospital	Hakodate	Hokkaido
Japan	Hakodate Ohmura Orthopedic Hospital	Hakodate	Hokkaido
Japan	Hamamatsu University School of Medicine, University Hospital	Hamamatsu	Shizuoka
Japan	Fukuoka Mirai Hospital	Higashi-ku,Fukuoka	Fukuoka
Japan	Kobe Konan Yamate Clinic	Higashinada-ku, Kobe	Hyogo
Japan	Sobajima Clinic	Higashiosaka	Osaka
Japan	Omuro Orthopedic Clinic	Himeji	Hyogo
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Hiroshima
Japan	Chiba Rosai Hospital	Ichihara	Chiba
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Medical corporate corporation hoshikai Onishi medical clinic	Kako-gun	Hyogo
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Kobe Red Cross Hospital	Kobe	Hyogo
Japan	Kyushu Rosai Hospital	Kokuraminami-ku,Kitakyushu	Fukuoka
Japan	Morita Hospital	Komatsu	Ishikawa
Japan	Saitama Jikei Hospital	Kumagaya	Saitama
Japan	Marunouchi Hospital	Matsumoto	Nagano
Japan	Tokyo Saiseikai Central Hospital	Minato-ku	Tokyo
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	Takagi Hospital	Okawa	Fukuoka
Japan	Saitama Municipal Hospital	Saitama
Japan	Shimonoseki City Hospital	Shimonoseki-shi	Yamaguchi
Japan	Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital	Shinagawa-ku	Tokyo
Japan	Ohimachi Orthopaedic Clinic	Shinagawa-ku	Tokyo
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Nagoya University Hospital	Showa-ku, Nagoya	Aichi
Japan	Minamiosaka Hospital	Suminoe-ku, Osaka	Osaka
Japan	Toyama University Hospital	Toyama
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Chiba Central Medical Center	Wakaba-ku, Chiba	Chiba
Japan	Yonezawa City Hospital	Yonezawa	Yamagata
Korea, Republic of	Clinical Trial Pharmacy, Samsung Medical Center	Seoul
Korea, Republic of	CTC Pharmacy, Seoul National University Hospital	Seoul
Korea, Republic of	CTC Pharmacy, Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Spain	Complejo Hospitalario Universitario A Coruña	A Coruna
Spain	Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia	A Coruna
Spain	Instituto de Ciencias Medicas	Alicante
Spain	Hospital de Mar Servicio de Radiologia	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital del Mar Servicio de Farmacia	Barcelona
Spain	Hospital Sanitas CIMA	Barcelona
Spain	Hospital Universitario Quiron-Dexeus	Barcelona
Spain	Hospital Universitario Quiron-Dexeus. Servicio de Farmacia	Barcelona
Spain	Specialist, S.L.	Barcelona
Spain	Specialist. Farmacia	Barcelona
Spain	Hospital La Moraleja	Madrid
Spain	Hospital La Moraleja. Pharmacy Service	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Paz.	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Hospital Regional Universitario del Malaga	Malaga
Spain	Hospital Nuestra Senora de la Esperanza	Santiago de Compostela	A Coruna
Sweden	CTC (Clinical Trial Center) Sahlgrenska University Hospital	Gothenburg
Sweden	Pharmasite	Helsingborg
Sweden	Pharmasite	Malmo
Sweden	ProbarE i Stockholm AB	Stockholm
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	New Mexico Clinical Research & Osteoporosis Center, Inc.	Albuquerque	New Mexico
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	KRK Medical Research	Arlington	Texas
United States	JEM Research Institute	Atlantis	Florida
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Clinical Inquest Center Ltd	Beavercreek	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Washington Center for Pain Management	Bellevue	Washington
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Cahaba Research	Birmingham	Alabama
United States	Central Alabama Research	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Willis-Knighton Physician Network/ Spine and Pain Specialist	Bossier City	Louisiana
United States	Willis-Knighton Physician Network/WKB Family Medicine Associates	Bossier City	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	New England Research Associates, LLC	Bridgeport	Connecticut
United States	Healthwise Medical Associates	Brooklyn	New York
United States	Investigators Research Group, LLC	Brownsburg	Indiana
United States	Valley Medical Research/Valley Medical Primary Care	Centerville	Ohio
United States	Core Healthcare Group	Cerritos	California
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Chicago Anesthesia Pain Specialists	Chicago	Illinois
United States	Chicago Clinical Research Institute, Inc.	Chicago	Illinois
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Medex Healthcare Research Inc	Chicago	Illinois
United States	Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Northwestern University, Feinberg School of Medicine, Lavin Pavilion	Chicago	Illinois
United States	eStudySite	Chula Vista	California
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	TLM Medical Services	Columbia	South Carolina
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Optimed Research LTD	Columbus	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Mayfield Imaging Center	Crestview Hills	Kentucky
United States	Klein & Associates, M.D., P.A.	Cumberland	Maryland
United States	Avail Clinical Research,LLC	DeLand	Florida
United States	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	Mountain View Clinical Research, Inc	Denver	Colorado
United States	Mountain View Clinical Research, Inc.	Denver	Colorado
United States	The Iowa Clinic	Des Moines	Iowa
United States	The Iowa Clinic - Internal Medicine	Des Moines	Iowa
United States	The Iowa Clinic Medical Imaging	Des Moines	Iowa
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Physicians Research Options, LLC	Draper	Utah
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Otri-Med Corporation	Edgewood	Kentucky
United States	St Elizabeth Hospital Edgewood	Edgewood	Kentucky
United States	Triwest Research Associates, LLC	El Cajon	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Plains Clinical Research Center, LLC	Fargo	North Dakota
United States	S&W Clinical Research	Fort Lauderdale	Florida
United States	Prestige Clinical Research	Franklin	Ohio
United States	Neuro-Pain Medical Center	Fresno	California
United States	Research Center of Fresno, Inc.	Fresno	California
United States	Valley Research-Trials	Fresno	California
United States	Heartland Diagnostics	Frgi	North Dakota
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Collaborative Neuroscience Network, LLC.	Garden Grove	California
United States	DeGarmo Institute of Medical Research	Greer	South Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Drug Trials America	Hartsdale	New York
United States	Pines Clinical Research Inc.	Hollywood	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Advances In Health	Houston	Texas
United States	Centex Studies, Inc./Clear Lake Family Physicians	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	CRC of Jackson, LLC	Jackson	Mississippi
United States	Physician's Surgery Center	Jackson	Mississippi
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	PCET Research Center, LLC	Knoxville	Tennessee
United States	eStudySite	La Mesa	California
United States	Lafayette Clinical Research Group	Lafayette	Indiana
United States	Lafayette Regional Vein and Laser Center	Lafayette	Indiana
United States	Centex Studies, Inc	Lake Charles	Louisiana
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Affiliated Clinical Research, Inc.	Las Vegas	Nevada
United States	Office of Robert Kaplan, DO	Las Vegas	Nevada
United States	Office of Stephen H. Miller, MD	Las Vegas	Nevada
United States	Northstate Clinical Research	Lenoir	North Carolina
United States	KLR Business Group dba Arkansas Clinical Research	Little Rock	Arkansas
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Primary Care of Arkansas, P.A.	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California
United States	University of Southern California	Los Angeles	California
United States	USC IDS Pharmacy	Los Angeles	California
United States	Drug Studies America	Marietta	Georgia
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
United States	Non-Surgical Orthopaedics, P.C.	Marietta	Georgia
United States	CRI Worldwide, LLC	Marlton	New Jersey
United States	Great Lakes Medical Research, LLC	Mentor	Ohio
United States	Oaktree Clinic	Mentor	Ohio
United States	Ferguson Family Medicine	Mesa	Arizona
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	Larkin Imaging Center	Miami	Florida
United States	M & M Medical Center, Inc	Miami	Florida
United States	Quality Research & Medical Center LLC	Miami	Florida
United States	Crystal Biomedical Research, LLC	Miami Lakes	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	My Health 1st Urgent Care	Milford	Connecticut
United States	Alabama Clinical Research, LLC	Mobile	Alabama
United States	Alabama Orthopaedic Clinic, P.C.	Mobile	Alabama
United States	Coastal Clinical Research	Mobile	Alabama
United States	Horizon Research Partners, LLC	Mobile	Alabama
United States	Catalina Research Institute, LLC	Montclair	California
United States	On Site Clinical Solutions, LLC	Mooresville	North Carolina
United States	Quality Medical Research	Nashville	Tennessee
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	George Stanley Walker, MD	New Orleans	Louisiana
United States	The Medical Research Network, LLC	New York	New York
United States	Better Health Clinical Research Inc	Newnan	Georgia
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Lowcountry Orthopaedics & Sports Medicine	North Charleston	South Carolina
United States	Providence Clinical Research	North Hollywood	California
United States	Sensible Healthcare, LLC.	Ocoee	Florida
United States	COR Clinical Research, L.L.C	Oklahoma City	Oklahoma
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	NPC Research	Oklahoma City	Oklahoma
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Heartland Clinical Research, Inc.	Omaha	Nebraska
United States	Compass Research, LLC	Orlando	Florida
United States	National Pain Research Institute	Orlando	Florida
United States	Mid-America Physiatrists, P.A.	Overland Park	Kansas
United States	Arizona Research Center	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	The Pain Relief Center	Plano	Texas
United States	Progressive Medical Research	Port Orange	Florida
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Beacon Clinical Research, LLC	Quincy	Massachusetts
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	AAIR Research Center	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	Michigan Orthopaedic Spine Surgeons	Rochester Hills	Michigan
United States	Northern California Research	Sacramento	California
United States	Medex Healthcare Research, Inc.	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Lee Medical Associates, PA	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Quality Research, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	The Center for Clinical Trials, Inc.	Saraland	Alabama
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	Southeast Regional Research Group	Savannah	Georgia
United States	Valley Pain Consultants	Scottsdale	Arizona
United States	Clinical Investigation Specialists, Inc.	Skokie	Illinois
United States	University Clinical Research Center	Somerset	New Jersey
United States	Encompass Clinical Research	Spring Valley	California
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Meridien Research	Tampa	Florida
United States	Bone Joint & Spine Surgeons, Inc.	Toledo	Ohio
United States	Premier Research	Trenton	New Jersey
United States	Oakland Medical Research	Troy	Michigan
United States	Bayview Research Group	Valley Village	California
United States	Buynak Clinical Research, P.C.	Valparaiso	Indiana
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	The Iowa Clinic	West Des Moines	Iowa
United States	The Iowa Clinic Medical Imaging	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Elite Clinical Trials, Inc.	Wildomar	California
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	North Georgia Internal Medicine	Woodstock	Georgia
United States	Michigan Pain Consultants	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Hungary,  Japan,  Korea, Republic of,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16	Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Week 16
Secondary	Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo	The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.	Baseline, Week 16
Secondary	Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16	Average LBP was assessed on an 11-point NRS captured through an IRT. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Week 16
Secondary	Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56	Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64	Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.	Baseline, Week 64
Secondary	Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56	The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data	The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.	Baseline, Weeks 64 and 80
Secondary	Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data	PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition.	Baseline, Week 64
Secondary	Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)	Average LBP was assessed on an 11-point NRS captured through an IRT. LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was imputed using mixed BOCF/LOCF.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Baseline, Weeks 16, 24 and 56
Secondary	Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)	Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with reduction in LBPI of at least (>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 compared to baseline were classified as responders to LBPI and are reported here, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Secondary	Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)	RMDQ: health status measure index of how well participants with LBP are able to function with regard to daily activities. Measures pain and function using 24 items describing limitations to everyday life. Total score of RMDQ is total number of items checked ranging from 0=no disability to 24=maximum disability, higher scores=greater disability. Percentage of participants with reduction in LBPI of at least (>=) 30, 50, 70 and 90% at specified weeks compared to baseline were classified as responders to LBPI and are reported here. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56	The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Percentage of participants with cumulative reduction (as percent) (>0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 %, 90% and =100 %) in RMDQ from Baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 16, 24 and 56
Secondary	Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.	Baseline, Week 64
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.	Baseline, Week 64
Secondary	Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56	Chronic Low Back Pain Responder Index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of Low Back Pain, and RMDQ total score. Participants were successful responders if they had: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in PGA of low back pain from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)	PGA of LBP assessed by asking question to participants:Considering all ways your low back pain affects you,how are you doing today? They responded on 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic & no limitation of normal activities);2=good (mild symptoms and no limitation of normal activities);3=fair (moderate symptoms and limitation of some normal activities);4=poor (severe symptoms & inability to carry out most normal activities); & 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. % of participants with improvement of at least 2 points from baseline in PGA of LBP were reported. Missing data was imputed using BOCF/LOCF. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Secondary	European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score	EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Individual dimension scores ranged from 1.0 (least impairment of health state) to 5.0 (most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.	Baseline, Weeks 8, 16, 24, 40 and 56
Secondary	European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value	EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.EQ-5D-5L consists of 2 components: a health state profile and an optional VAS.EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Individual dimension scores ranged from 1.0(least impairment of health state) to 5.0(most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.Responses from five domains were used to calculate a single utility index (Overall health utility score) where values are less than equal to (<=) 1.Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and reduced where participant reports greater levels of problems across five dimensions.	Baseline, Weeks 8, 16, 24, 40, 56 and 64
Secondary	Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data	WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to Week 16 was to analyze, participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16 in placebo arm, in pooled manner. Hence data have been reported per four arms.	Baseline
Secondary	Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64	WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Baseline, Weeks 16, 56 and 64
Secondary	Number of Participants Who Withdrew Due to Lack of Efficacy	Number of participants who withdrew from treatment due to lack of efficacy have been reported here.	Baseline up to Week 56
Secondary	Time to Discontinuation Due to Lack of Efficacy	Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.	Baseline up to Week 56
Secondary	Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64	In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of participants with any use of rescue medication during the particular study week were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.	Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Secondary	Number of Participants Who Took Rescue Medication During Week 64: Observed Data	In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.	Week 64
Secondary	Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56	In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days the participants used the rescue medication during the particular study weeks were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.	Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Secondary	Number of Days of Rescue Medication Used at Week 64	In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.	Week 64
Secondary	Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16	In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. The total dosage of acetaminophen in milligrams used during the specified week were summarized. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.	Weeks 2, 4, 8, 12 and 16
Secondary	Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (for Baseline during the last 3 months for baseline, weeks 64 and 80, via IRT). Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner. Participants might have been counted more than once under various categories.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who visited the emergency room due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of visits to the emergency room due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who were hospitalized due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of nights stayed in the hospital due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who quit job due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain	Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was duration since quitting job due to low back pain.	Baseline, Weeks 64 and 80
Secondary	Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56	TSQM v.II: self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (7 questions scored on 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]), effectiveness and side effects/tolerability (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied], 1 question on 2 point scale [0 =No, 1=Yes]). 11 questions of TSQM were used to calculate 4 endpoints of effectiveness, side effects, convenience and global satisfaction, each scored on a 0-100 scale with 100=best level of satisfaction. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Weeks 16 and 56
Secondary	Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?	The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Weeks 16 and 56
Secondary	Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?	mPRTI : self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment & preference to continue using investigational product) & participant willingness to use drug again assessment. To assess preference to continue using investigational product, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Weeks 16 and 56
Secondary	Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?	mPRTI: self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) & participant willingness to use drug again assessment. To assess participants willingness to use drug again, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.	Weeks 16 and 56
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 80 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.	Baseline up to Week 80
Secondary	Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56	Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to W56 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. Pre-specified intent of study for summaries for the entire treatment period (up to week 56), data was summarized by 3 arms.	Baseline up to Week 56
Secondary	Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline	Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; WBC count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8; Urine Glucose, protein,HGB,bilirubin >=1; Ketones>=1;Urine erythrocytes,Leukocytes>=20.	Baseline up to Week 80
Secondary	Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline	Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; Nitrite >=1.	Baseline up to Week 80
Secondary	Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary	Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary	Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80	A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals {RR interval, PR interval, QRS interval, QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF)} were collected. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 16, 56 and 80
Secondary	Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80	Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 16, 56 and 80
Secondary	Number of Participants With Confirmed Orthostatic Hypotension	Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary	Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80	The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80
Secondary	Percentage of Participants With Adjudicated Joint Safety Outcomes	Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.	Baseline up to Week 80
Secondary	Percentage of Participants With Total Joint Replacements	Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.	Baseline up to Week 80
Secondary	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80	NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Secondary	Number of Participants With Anti Tanezumab Antibodies	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.	Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80

External Links

•   To obtain contact information for a study center near you, click here.