Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
1 other identifier
interventional
529
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2003
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedResults Posted
Study results publicly available
September 28, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.2 years
April 11, 2006
July 28, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
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.
Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
Secondary Outcomes (1)
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.
Study Arms (2)
BTDS
EXPERIMENTALBuprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
Placebo
PLACEBO COMPARATORPlacebo to match BTDS 5, 10 or 20 mcg/h
Interventions
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (44)
Vista Medical Research
Mesa, Arizona, 85206, United States
Arizona Research Center
Phoenix, Arizona, 85012, United States
Radiant Research
Phoenix, Arizona, 85013, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
ACRC/Arizona Clinical Research
Tucson, Arizona, 85715, United States
Advance Pain Medicine
Bakersfield, California, 93311, United States
Eastgate Medical Center
Cypress, California, 90623, United States
University Osteoporosis Ctr
Loma Linda, California, 92354, United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92108, United States
Scripps Clinic Rancho Bernard
San Diego, California, 92128, United States
CNS Clinical Trials, Inc
San Francisco, California, 94121, United States
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Integrative Treatment Centers/Rocky Mtn Clin Res
Westminster, Colorado, 80021, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Stamford Therapeutic Consortium
Bridgeport, Connecticut, 66060, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462, United States
University Clinical Research Deland
DeLand, Florida, 32720, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Coastal Medical Research
Orange City, Florida, 32763, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Gold Coast Research
Weston, Florida, 33331, United States
Non-Surgical Orthopedic & Spine Center
Marietta, Georgia, 30060, United States
Columbus Internal Medical Associates
Columbus, Indiana, 47201, United States
MediSphere Medical Research Ctr.
Evansville, Indiana, 47714, United States
Primary Care Research
Murray, Kentucky, 42071, United States
Professional Clinical Research
Cadillac, Michigan, 49601, United States
Sound Medical At West Front Primary Care
Traverse City, Michigan, 49684, United States
Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
New York, New York, 10003, United States
All-Trials Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Keystone Clinical
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611, United States
Low Country Rheumatology
Charleston, South Carolina, 29406, United States
Brown Clinic
Watertown, South Dakota, 57201, United States
Private Practice
Dallas, Texas, 75251, United States
Team Research of Central Texas
Harker Heights, Texas, 76548, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
ACCU Clinical Research Trials, Inc
Seguin, Texas, 78155, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Advance Pain Management & Rehab
Virgina Beach, Virginia, 23454, United States
Evergreen Clinical Research Associates
Edmonds, Washington, 98026, United States
Internal Medicine Northwest
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 12, 2006
Study Start
April 1, 2003
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
September 3, 2012
Results First Posted
September 28, 2010
Record last verified: 2012-08