Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
- Conditions
- Osteoarthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00313846
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) 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 situations for the relief of moderate to severe pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 529
- clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
- ingest opioid analgesics on a daily basis.
- ingest >2500 milligrams (mg) acetaminophen on a daily basis.
- require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS Buprenorphine transdermal patch Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) Placebo Placebo Placebo to match BTDS 5, 10 or 20 mcg/h
- Primary Outcome Measures
Name Time Method The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods Inadequate analgesia:
* "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
* \>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
* ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
- Secondary Outcome Measures
Name Time Method Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).
Trial Locations
- Locations (42)
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States
ACRC/Arizona Clinical Research
🇺🇸Tucson, Arizona, United States
Palm Beach Research Center
🇺🇸W. Palm Beach, Florida, United States
University Clinical Research Deland
🇺🇸Deland, Florida, United States
Gold Coast Research
🇺🇸Weston, Florida, United States
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Coastal Medical Research
🇺🇸Port Orange, Florida, United States
Professional Clinical Research
🇺🇸Cadillac, Michigan, United States
Advance Pain Medicine
🇺🇸Bakersfield, California, United States
Non-Surgical Orthopedic & Spine Center
🇺🇸Marietta, Georgia, United States
Integrative Treatment Centers/Rocky Mtn Clin Res
🇺🇸Westminster, Colorado, United States
Primary Care Research
🇺🇸Murray, Kentucky, United States
ACCU Clinical Research Trials, Inc
🇺🇸Seguin, Texas, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Eastgate Medical Center
🇺🇸Cypress, California, United States
Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
🇺🇸New York, New York, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
University Osteoporosis Ctr
🇺🇸Loma Linda, California, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Advance Pain Management & Rehab
🇺🇸Virgina Beach, Virginia, United States
Brown Clinic
🇺🇸Watertown, South Dakota, United States
Evergreen Clinical Research Associates
🇺🇸Edmonds, Washington, United States
MediSphere Medical Research Ctr.
🇺🇸Evansville, Indiana, United States
Radiant Research San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Team Research of Central Texas
🇺🇸Harker Heights, Texas, United States
Stamford Therapeutic Consortium
🇺🇸Bridgeport, Connecticut, United States
Columbus Internal Medical Associates
🇺🇸Columbus, Indiana, United States
Vista Medical Research
🇺🇸Mesa, Arizona, United States
Scripps Clinic Rancho Bernard
🇺🇸San Diego, California, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
San Diego Arthritis & Osteoporosis Medical Clinic
🇺🇸San Diego, California, United States
CNS Clinical Trials, Inc
🇺🇸San Francisco, California, United States
Medical Specialists of the Palm Beaches
🇺🇸Atlantis, Florida, United States
Sound Medical At West Front Primary Care
🇺🇸Traverse City, Michigan, United States
All-Trials Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Keystone Clinical
🇺🇸Altoona, Pennsylvania, United States
Internal Medicine Northwest
🇺🇸Tacoma, Washington, United States
Clinical Research Center of Reading, LLP
🇺🇸West Reading, Pennsylvania, United States
Low Country Rheumatology
🇺🇸Charleston, South Carolina, United States
Private Practice
🇺🇸Dallas, Texas, United States