Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
CompletedPhase 3NCT00313846
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Sponsor
- Purdue Pharma LP
- Start date
- 2003-04
- Primary completion
- 2004-06
- Sex
- All
- Age range
- from 40 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 44
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00313846