Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Diabetic Neuropathy, Painful Clinical Trial

Official title:

A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057693
• Other study ID #: A0081242
• Secondary ID: 2009-017389-21
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2010
• Est. completion date: January 30, 2012

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: January 30, 2012
• Est. primary completion date: January 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

• Patients with other pain conditions cannot participate.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• pregabalin (Lyrica)
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
• Placebo
Placebo is supplied as capsules and given 3 times daily.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Capital District Health Authority, QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Capital District Health Authority, QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	The Ottawa Hospital, Riverside Campus - Riverside Professional Building	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
Canada	Winnipeg Regional Health Authority Sciences Centre Winnipeg	Winnipeg	Manitoba
Puerto Rico	Ponce School of Medicine & Health Sciences	Ponce
Puerto Rico	Instituto de Endocrinologia Diabetes y Metabolismo	Toa Baja
South Africa	Bloemfontein Medi-Clinic	Bloemfontein	FREE State
South Africa	Centre for Diabetes and Endocrinology	Durban	Kwazulu Natal
South Africa	Chelmsford Medical Centre	Durban	Kwazulu Natal
South Africa	Dot Shuttleworth Centre for Diabetes	Durban	Overport
South Africa	Randles Road Medical Centre	Durban	Kwa-zulu Natal
South Africa	Centre for Diabetes and Endocrinology	Houghton, Johannesburg
South Africa	Dr Makan's Rooms	Johannesburg	Gauteng
South Africa	Parklands Medical Centre	Overport	Kwazulu Natal
South Africa	102 Parklands Medical Centre	Overport, Durban
South Africa	Dr's Sauermann and Meyer	Polokwane
South Africa	Diabetes Care Centre	Pretoria
South Africa	Chris Hani Baragwanath Hospital	Soweto	Gauteng
South Africa	Dr Jeevren Reddy's Surgery	Stanger	Kwazulu Natal
United States	Aiken Center for Clinical Research	Aiken	South Carolina
United States	Radiant Research, Inc.	Akron	Ohio
United States	Blair Orthopedic Associates, Inc.	Altoona	Pennsylvania
United States	Convergys Clinical Research, Inc.	Anaheim	California
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	NeuroTrials Research, Incorporated	Atlanta	Georgia
United States	AMR Sakeena Research	Aurora	Illinois
United States	Aurora Family Medicine Center, PC	Aurora	Colorado
United States	CPM Research Institute	Austell	Georgia
United States	Greystone Medical Research, LLC	Birmingham	Alabama
United States	Alpine Clinical Research Center, Inc.	Boulder	Colorado
United States	Metabolic Research Institute, Inc.	Boynton Beach	Florida
United States	Bradenton Research Center	Bradenton	Florida
United States	Meridien Research	Bradenton	Florida
United States	Miray Medical Center	Brockton	Massachusetts
United States	Meridien Research	Brooksville	Florida
United States	Providence Clinical Research	Burbank	California
United States	ClinRx Research LLC	Carrollton	Texas
United States	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee
United States	Chicago Research Center, Inc.	Chicago	Illinois
United States	Community Research	Cincinnati	Ohio
United States	Radiant Research	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	TLM Medical Services, LLC	Columbia	South Carolina
United States	University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center	Columbia	Missouri
United States	Columbus Research Foundation	Columbus	Georgia
United States	Rockdale Medical Research Associates	Conyers	Georgia
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Providence Health Partners - Center for Clinical Research	Dayton	Ohio
United States	Deerfield Beach Cardiology Research	Deerfield Beach	Florida
United States	Mountain View Clinical Research	Denver	Colorado
United States	Harris and Associates MD, PC	Detroit	Michigan
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Coastal Medical	East Greenwich	Rhode Island
United States	MAPS Applied Research Center, Inc.	Edina	Minnesota
United States	Medical Advanced Pain Specialists (MAPS)	Edina	Minnesota
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Medical Group of Texas	Fort Worth	Texas
United States	Valley Research	Fresno	California
United States	SCRI Research Center	Germantown	Tennessee
United States	Horizon Clinical Research Associates, PLLC	Gilbert	Arizona
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Dedicated Clinical Research, Inc.	Goodyear	Arizona
United States	American Health Network	Greenfield	Indiana
United States	Radiant Research Inc.	Greer	South Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Desert Endocrinology Clinical Research Center	Henderson	Nevada
United States	Neurological Associates, Incorporated	Henrico	Virginia
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Central Arkansas Research	Hot Springs	Arkansas
United States	The Nerve and Muscle Center of Texas	Houston	Texas
United States	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana
United States	CRC of Jackson	Jackson	Mississippi
United States	Physician's Surgery Center	Jackson	Mississippi
United States	Sarah Cannon Research Institute	Jackson	Tennessee
United States	Borgess Diabetes Center	Kalamazoo	Michigan
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Endocrinology Center of Southwest Louisiana	Lake Charles	Louisiana
United States	Heartland Research, LLC	Lake Charles	Louisiana
United States	Primary Physician Care, LLC	Lake Charles	Louisiana
United States	Center for United Research, Inc.	Lakewood	California
United States	Desert Endocrinology	Las Vegas	Nevada
United States	Office of Dr. Danka Michaels, MD	Las Vegas	Nevada
United States	Office of Stephen Miller, M.D.	Las Vegas	Nevada
United States	Kentucky Medical Research Center	Lexington	Kentucky
United States	Lincoln Internal Medicine Associates	Lincoln	Nebraska
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	Healthcare Partners Medical Group	Los Angeles	California
United States	University of Southern California, Keck School of Medicine, Department of Neurology	Los Angeles	California
United States	Richard S. Cherlin, MD	Los Gatos	California
United States	Medical Advanced Pain Specialists	Maple Grove	Minnesota
United States	Melinda A. Crockett-Maples	Marionville	Missouri
United States	AM Diabetes & Endocrinology Center	Memphis	Tennessee
United States	Memphis Internal Medicine	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Novara Clinical Research	Mesa	Arizona
United States	Elite Research Institute	Miami	Florida
United States	Aurora Advanced Healthcare, Inc.	Milwaukee	Wisconsin
United States	Arthritis and Diabetes Clinic, Inc	Monroe	Louisiana
United States	L. Craig Larsen and Clark C. Larsen	Murray	Utah
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	Laszlo J. Mate, MD	North Palm Beach	Florida
United States	Neurology Clinic, PC	Northport	Alabama
United States	Northridge Neurological Research	Northridge	California
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	Family Care Specialists, Inc.	Ocala	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Angelique Barreto, MD	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Veronique Sebastian, MD	Oklahoma City	Oklahoma
United States	Randall T. Huling, Jr., MD, CPI	Olive Branch	Mississippi
United States	Neurology and Pain Clinic, LLC	Orangeburg	South Carolina
United States	Aspen Clinical Research	Orem	Utah
United States	Compass Research, LLC	Orlando	Florida
United States	Palm Beach Neurological Center, Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida
United States	Suncoast Clinical Research	Palm Harbor	Florida
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Arizona Research Center	Phoenix	Arizona
United States	Research Protocol Management Specialists	Pittsburgh	Pennsylvania
United States	Remek Research	Pomona	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	ClinRx Research, LLC	Richardson	Texas
United States	Prism Research Group	Rome	Georgia
United States	Valley Health Care	Rome	Georgia
United States	Sierra Clinical Research	Roseville	California
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	KMED Research	Saint Clair Shores	Michigan
United States	A & A Pain Institute of Saint Louis	Saint Louis	Missouri
United States	Mercy Health Research	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Daniel B. Vine, MD	Salt Lake City	Utah
United States	Jean Brown Research	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Alamo Clinical Research	San Antonio	Texas
United States	Cetero Research - San Antonio	San Antonio	Texas
United States	Paragon Research Center, LLC	San Antonio	Texas
United States	CNRI-San Diego, LLC	San Diego	California
United States	San Diego Clinical Trials	San Diego	California
United States	Center for Clinical Research, Inc.	San Francisco	California
United States	Apex Research Institute	Santa Ana	California
United States	Neurological Research Institute	Santa Monica	California
United States	Radiant Research, Inc.	Scottsdale	Arizona
United States	Medical Advanced Pain Specialists	Shakopee	Minnesota
United States	Spokane Internal Medicine	Spokane	Washington
United States	Clinvest	Springfield	Missouri
United States	Carolina Pharmaceutical Research	Statesville	North Carolina
United States	Pioneer Research Solutions, Inc	Sugar Land	Texas
United States	Neurology Clinical Research, Inc.	Sunrise	Florida
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Meridien Research	Tampa	Florida
United States	Troy Internal Medicine, PC	Troy	Michigan
United States	William Beaumont Hospital	Troy	Michigan
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Foothills Pain Management	West Covina	California
United States	Foot and Ankle Clinic	West Jordan	Utah
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline, Week 19 (DB Phase)
Secondary	Time to Loss of Pain Response (Double-Blind Phase)	Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline up to Week 19
Secondary	Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline, Week 6 (SB Phase)
Secondary	Weekly Mean Pain Scores (Single-Blind Phase)	Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.	Week 1, 2, 3, 4, 5, 6
Secondary	Weekly Mean Pain Scores (Double-Blind Phase)	Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.	DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Secondary	Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.	Week 6
Secondary	Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.	Week 19
Secondary	Patient Global Impression of Change (PGIC) (Single-Blind Phase)	PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.	Week 6
Secondary	Patient Global Impression of Change (PGIC) (Double-Blind Phase)	PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.	Week 19
Secondary	Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)	Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.	SB Baseline, Week 6
Secondary	Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)	Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.	Week 19
Secondary	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.	SB Baseline, Week 6
Secondary	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.	Week 19
Secondary	Weekly Mean Sleep Interference Score (Single-Blind Phase)	Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.	SB Baseline, Week 1, 2, 3, 4, 5, 6
Secondary	Weekly Mean Sleep Interference Score (Double-Blind Phase)	Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).	DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Secondary	Endpoint Mean Sleep Interference Score (Single-Blind Phase)	Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).	Week 6
Secondary	Endpoint Mean Sleep Interference Score (Double-Blind Phase)	Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).	Week 19
Secondary	Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)	QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.	SB Baseline, Week 6
Secondary	Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)	QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.	Week 19
Secondary	Pain Visual Analog Scale (VAS) (Single-Blind Phase)	Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.	SB Baseline, Week 6
Secondary	Pain Visual Analog Scale (VAS) (Double-Blind Phase)	Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.	Week 19
Secondary	Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)	BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).	SB Baseline, Week 6
Secondary	Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)	BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).	Week 19
Secondary	Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)	HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.	SB Baseline, Week 6
Secondary	Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)	HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.	Week 19
Secondary	Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)	GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.	Week 6
Secondary	Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)	GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.	Week 19

External Links

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