The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
CompletedPhase 3NCT00315445
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 assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Study details
- Official title
- A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
- Conditions
- Interventions
- Drug: Buprenorphine transdermal patch
- Drug: Placebo oxycodone/acetaminophen tablets
- Drug: OXY/APAP
- Drug: Placebo transdermal patch (TDS)
- Sponsor
- Purdue Pharma LP
- Start date
- 1997-12
- Primary completion
- 1998-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 12
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions. * unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day. Exclusion Criteria: * receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products. * scheduled to have surgery (including dental) involving the use of preoperative or postoperative 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/NCT00315445