Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
- Conditions
- Chronic PainOsteoarthritis of the Knee
- Interventions
- Drug: Placebo
- Registration Number
- NCT00531427
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
- Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 567
- subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
- clinical diagnosis of OA of the knee 1 year or longer,
- subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
- subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.
- subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
- subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
- subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Other protocol-specific inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Buprenorphine Buprenorphine transdermal system 10 and 20 applied for 7-day wear 2 Placebo Placebo transdermal system to match BTDS patches, applied for 7-day wear
- Primary Outcome Measures
Name Time Method "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. 24 hours (week 12) "Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.
- Secondary Outcome Measures
Name Time Method Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. 10 weeks Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. Weeks 4, 8, and 12 of the double-bind phase The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Trial Locations
- Locations (26)
Stat-Lab I, Inc.
🇺🇸Baton Rouge, Louisiana, United States
Arthritis Clinic, PLLC
🇺🇸Jackson, Tennessee, United States
Coastal Pain Management
🇺🇸Bradenton, Florida, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Rehabilitation Association of IN
🇺🇸Indianapolis, Indiana, United States
Digestive Endoscopy Center
🇺🇸Dayton, Ohio, United States
Oyster Point Family Health Ctr
🇺🇸Lancaster, Pennsylvania, United States
Arizona Research Center, Inc.
🇺🇸Phoenix, Arizona, United States
Research Facility
🇺🇸Salt Lake City, Utah, United States
Clinical Research of West Flor
🇺🇸Tampa, Florida, United States
Independence Family Medicine
🇺🇸Virginia Beach, Virginia, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
Paramount Clinical Research
🇺🇸Bridgeville, Pennsylvania, United States
Pacific Northwest Primary Care
🇺🇸Tacoma, Washington, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Sports Med Consultants PC
🇺🇸St. Louis, Missouri, United States
Catalina Research Institute
🇺🇸Chino, California, United States
East Coast Clinical Research
🇺🇸Haverhill, Massachusetts, United States
Premier Internal Medicine
🇺🇸Biloxi, Mississippi, United States
NDC Medical Center
🇺🇸Norfolk, Virginia, United States
Radiant Research, Phoenix Southeast
🇺🇸Chandler, Arizona, United States
AMR Research Associates
🇺🇸Bogart, Georgia, United States
New England Center for Clinical Research
🇺🇸Cranston, Rhode Island, United States
Greenville Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States