The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
CompletedPhase 3NCT00315848
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 (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
Study details
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
- Conditions
- Interventions
- Sponsor
- Purdue Pharma LP
- Start date
- 1996-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 10
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day. * taking \>/=3 opioid doses per day with or without acceptable pain control. Exclusion Criteria: * receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. * scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. 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/NCT00315848