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
Verified date | February 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Canada, Puerto Rico, South Africa,
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 |
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