Extension Study Of Tanezumab In Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809783
• Other study ID #: A4091016
• Secondary ID: P3 LONG TERM SAF
• Status: Terminated
• Phase: Phase 3
• Start date: February 6, 2009
• Est. completion date: June 23, 2011

Study information

• Verified date: April 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Description:

This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2147
• Est. completion date: June 23, 2011
• Est. primary completion date: November 2, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

• Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• tanezumab
Tanezumab 10 mg
• tanezumab
Tanezumab 5 mg
• tanezumab
Tanezumab 2.5 mg

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	New Mexico Clinical Research & Osteoporosis Center, Incorporated	Albuquerque	New Mexico
United States	McFarland Clinic, PC	Ames	Iowa
United States	Ann Arbor Clinical Research	Ann Arbor	Michigan
United States	Anniston Medical Clinic, PC	Anniston	Alabama
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Pinncale Research Group, LLC	Anniston	Alabama
United States	Commonwealth Orthopaedics and Rehabilitation, PC	Arlington	Virginia
United States	IntegraTrials, LLC	Arlington	Virginia
United States	Virginia Hospital Center	Arlington	Virginia
United States	Arthritis and Rheumatology of Georgia	Atlanta	Georgia
United States	Laureate Clinical Research Group	Atlanta	Georgia
United States	Laureate Clinical Research Group	Atlanta	Georgia
United States	Maine Research Associates	Auburn	Maine
United States	Masters of Clinical Research, Inc.	Augusta	Georgia
United States	Colorado Orthopedic Consultants, PC	Aurora	Colorado
United States	Capitol Medical Clinic	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Walter F. Chase, MD, PA	Austin	Texas
United States	Bone and Joint Clinic of Baton Rouge	Baton Rouge	Louisiana
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	Stanocola Medical Center	Baton Rouge	Louisiana
United States	The Baton Rouge Clinic	Baton Rouge	Louisiana
United States	Great Lakes Research Group, Incorporated	Bay City	Michigan
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	Osteoporosis Medical Center	Beverly Hills	California
United States	Greystone Medical Center	Birmingham	Alabama
United States	Millennium Pain Center	Bloomington	Illinois
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Sonora Clinical Research, LLC.	Boise	Idaho
United States	HeartCare (Private Practice)	Bradenton	Florida
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Miray Medical Center	Brockton	Massachusetts
United States	SPRI Bronx LLC	Bronx	New York
United States	Arthritis and Osteoporosis Medical Associates	Brooklyn	New York
United States	Providence Clinical Research	Burbank	California
United States	Peak Anesthesia and Pain Management	Centennial	Colorado
United States	Low Country Rheumatology, PA	Charleston	South Carolina
United States	Arthritis and Osteoporosis Consultants of the Carolinas	Charlotte	North Carolina
United States	Carolina Bone & Joint, PA	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	eStudySite	Chula Vista	California
United States	Consultants for Clinical Research Incorporated	Cincinnati	Ohio
United States	Hilltop Medical Research Center	Cincinnati	Ohio
United States	Ohio GI and Liver Institute	Cincinnati	Ohio
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Tampa Bay Medical Research, Inc.	Clearwater	Florida
United States	The Family Healthcare Center, PA	Clinton	South Carolina
United States	Southern Orthopaedic Sports Medicine	Columbia	South Carolina
United States	Columbus Clinical Research, Inc.	Columbus	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Crown Imaging	Dallas	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	North Texas Joint Care, PA	Dallas	Texas
United States	Radiant Research	Dallas	Texas
United States	Clinical Research Center of Connecticut	Danbury	Connecticut
United States	PHP Center for Clinical Research	Dayton	Ohio
United States	Jefrey D. Lieberman, MD	Decatur	Georgia
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Arthritis Associates of South Florida	Delray Beach	Florida
United States	Delray Research Associates	Delray Beach	Florida
United States	Advanced Orthopedic and Sports Medicine	Denver	Colorado
United States	Denver Internal Medicine Group	Denver	Colorado
United States	Mountain View Clinical Research, Inc.	Denver	Colorado
United States	In Vivo Clinical Research, Inc	Doral	Florida
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MAPS Applied Research Center Inc.	Edina	Minnesota
United States	Medical Advanced Pain Specialists	Edina	Minnesota
United States	American Clinical Research, LLC	Englewood	Colorado
United States	Colorado Hematology - Oncology	Englewood	California
United States	Colorado Orthopedic Consultants, PC	Englewood	California
United States	Orthopaedic Physicians Of Colorado, P.C.	Englewood	Colorado
United States	University Parks Hematology/Oncology	Englewood	Colorado
United States	Arthritis Medical Clinic of North County, Inc.	Escondido	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Odyssey Research	Fargo	North Dakota
United States	Plains Medical Clinic, LLC	Fargo	North Dakota
United States	American Health Network	Fishers	Indiana
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	S & W Clinical Research	Fort Lauderdale	Florida
United States	Early Family Practice Center	Fort Valley	Georgia
United States	Edinger Medical Group Clinical Research	Fountain Valley	California
United States	Arthritis Treatment Center	Frederick	Maryland
United States	Valley Research	Fresno	California
United States	Northeast Georgia Diagnostic Clinic, LLC	Gainesville	Georgia
United States	O. David Taunton, Jr, MD	Grapevine	Texas
United States	Pharmquest	Greensboro	North Carolina
United States	Diagnostic Center of Medicine	Henderson	Nevada
United States	Mid-Atlantic Medical Research Centers	Hollywood	Maryland
United States	St. Joseph's Mercy Clinic	Hot Springs	Arkansas
United States	Asif Cochinwala, MD, PA	Houston	Texas
United States	Foundation for Southwest Orthopedic Research	Houston	Texas
United States	One Step Diagnostic	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Southwest Orthopedic Group	Houston	Texas
United States	The Neurology Center	Houston	Texas
United States	Talbert Medical Group	Huntington Beach	California
United States	Saadat Ansari, MD Office	Huntsville	Alabama
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	State of Franklin Healthcare Associates, PLLC	Johnson City	Tennessee
United States	Holston Medical Group	Kingsport	Tennessee
United States	Lakewood Orthopedic Medical & Surgical Group	Lakewood	California
United States	High Desert Medical Group Research for Life	Lancaster	California
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	G. Timothy Kelly, MD	Las Vegas	Nevada
United States	Independent Clinical Researchers	Las Vegas	Nevada
United States	Mirkil Medical	Las Vegas	Nevada
United States	Office of Dr. Danka Michaels, MD	Las Vegas	Nevada
United States	Wolfson Medical Center	Las Vegas	Nevada
United States	Delaware Arthritis	Lewes	Delaware
United States	Arthritis Center of Lexington	Lexington	Kentucky
United States	Bluegrass Community Research, Inc	Lexington	Kentucky
United States	Pasadena Pharmacy	Lexington	Kentucky
United States	The Pain Treatment Center of the Bluegrass	Lexington	Kentucky
United States	Premiere Clinical Research, LLC	Long Beach	California
United States	Adult Medicine Specialists	Longwood	Florida
United States	Genesis Research International	Longwood	Florida
United States	Samaritan Center for Medical Research	Los Gatos	California
United States	David H. Neustadt, MD	Louisville	Kentucky
United States	L-Marc Research Center	Louisville	Kentucky
United States	Gill Orthopedic Center	Lubbock	Texas
United States	Robert R. King, M.D.	Lubbock	Texas
United States	Mansfield Health Center	Mansfield	Massachusetts
United States	Marietta Rheumatology Associates	Marietta	Georgia
United States	Clinical Research Advantage, Inc.	Mesa	Arizona
United States	Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC	Mesa	Arizona
United States	Clinical Research Advantage, Inc./Mesa Family Medical Center, PC	Mesa	Arizona
United States	Novara Clinical Research	Mesa	Arizona
United States	Kendall South Medical Center, Inc.	Miami	Florida
United States	Pharmax Research Clinic, Inc	Miami	Florida
United States	Paramount Medical Research and Consulting, LLC	Middleburg Heights	Ohio
United States	Orthopaedic & Sports Medicine Consultants	Middletown	Ohio
United States	Signal Point Clinical Research Center	Middletown	Ohio
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Horizon Research Group	Mobile	Alabama
United States	Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	Koch Family Medicine	Morton	Illinois
United States	Illinois Bone and Joint Institute, LLC	Morton Grove	Illinois
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Medex Healthcare Research	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Javed Rheumatology Associates, Inc.	Newark	Delaware
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	Norwalk Medical Group	Norwalk	Connecticut
United States	Cor Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Midwest Minor Medical	Omaha	Nebraska
United States	Midwest Minor Medical	Omaha	Nebraska
United States	Midwest Minor Medical	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Sunshine Research Center	Opa-locka	Florida
United States	Aspen Clinical Research	Orem	Utah
United States	Compass Research, LLC	Orlando	Florida
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	The Arthritis Center	Palm Harbor	Florida
United States	Arizona Arthritis & Rheumatology Research, PLLC	Paradise Valley	Arizona
United States	Advanced Orthopedic and Sports Medicine	Parker	Colorado
United States	Arthritis Associates Inc.	Peabody	Massachusetts
United States	University Clinical Research Incorporated	Pembroke Pines	Florida
United States	Pivotal Research Center	Peoria	Arizona
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Phoenix	Arizona
United States	Arizona Research Center	Phoenix	Arizona
United States	Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC	Phoenix	Arizona
United States	Clinical Research Advantage, Inc.	Phoenix	Arizona
United States	Advent Clinical Research Centers, Inc.	Pinellas Park	Florida
United States	Prem C. Chatpar, MD, LLC	Plainview	New York
United States	Clinical Investigations of Texas, LLC	Plano	Texas
United States	Planters Clinic	Port Gibson	Mississippi
United States	Progressive Medical Research	Port Orange	Florida
United States	Office of Doris M. Rice, MD, FACR	Portsmouth	Virginia
United States	Health Concepts	Rapid City	South Dakota
United States	Del Carmen Medical Center	Reseda	California
United States	HhypotheTest, LLC	Roanoke	Virginia
United States	AAIR Research Center	Rochester	New York
United States	The Carolina Center for Rheumatology and Arthritis Care, PA	Rock Hill	South Carolina
United States	Office of Dr. Andrew Porges	Roslyn	New York
United States	KMED Research	Saint Clair Shores	Michigan
United States	Medex Healthcare Research	Saint Louis	Missouri
United States	Mercy Health Research	Saint Louis	Missouri
United States	Dale G. Bramlet, MD, P.L.	Saint Petersburg	Florida
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Incorporated/Foothill Family Clinic South	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	Radiant Research San Antonio Northeast	San Antonio	Texas
United States	Texas Arthritis Research Center, PA	San Antonio	Texas
United States	Probe Clinical Research, Corp.	Santa Ana	California
United States	Trinity Clinical Trials	Santa Ana	California
United States	HeartCare Research	Sarasota	Florida
United States	Empirical Clinical Trials	Selah	Washington
United States	Memorial Medical Group Clinical Research Institute	South Bend	Indiana
United States	Arthritis Northwest	Spokane	Washington
United States	Spring Family Practice Associates PA	Spring	Texas
United States	St. John's Clinic - Neurology	Springfield	Missouri
United States	St. John's Medical Research Institute, Inc.	Springfield	Missouri
United States	The Arthritis Center	Springfield	Illinois
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	AZ Clinical Research	Sugar Land	Texas
United States	Spring Clinical Research	Sugar Land	Texas
United States	Sugar Land Med-Ped, P.A.	Sugar Land	Texas
United States	West Broward Rheumatology Associates, Inc.	Tamarac	Florida
United States	Tampa Medical Group, PA	Tampa	Florida
United States	Office of Lawrence P McAdam, MD	Thousand Oaks	California
United States	Paradigm Clinical, Inc.	Tucson	Arizona
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Quality of Life Medical and Research Center	Tucson	Arizona
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Westlake Medical Research	Westlake Village	California
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	North Georgia Internal Medicine	Woodstock	Georgia
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania
United States	Clinical Trials Northwest	Yakima	Washington
United States	Pharmacotherapy Research Associates,Inc	Zanesville	Ohio
United States	Physicians' Research, Inc	Zanesville	Ohio
United States	Primecare of Southeastern Ohio, Inc	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Classified According to Number of Intravenous Doses of Study Medication	Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.	A4091016: Baseline (Day 1) up to Week 64
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of 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 are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.	A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
Primary	Number of Participants With Abnormal Laboratory Findings	Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).	A4091016: Day 1 up to Week 80
Primary	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.	A4091016: Baseline (Day 1) up to Week 80
Secondary	Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Secondary	Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab	Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.	A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)
Secondary	Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings	Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.	Baseline (Day 1) up to Week 80
Secondary	Number of Participants With Clinically Significant Abnormality in Vital Signs	Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.	A4091016: Baseline (Day 1) up to Week 80
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response	OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 1)WOMAC pain subscale, 2)WOMAC physical function subscale, 3)PGA of osteoarthritis (score: 1-5, higher score=more affected).WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score:0-10, higher score=higher pain/difficulty).	A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104
Secondary	Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104
Secondary	Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis	Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Secondary	Percentage of Participants Who Used Concomitant Analgesic Medication	United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.	Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
Secondary	Days Per Week of Concomitant Analgesic Medication Usage	FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.	Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112

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