Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
CompletedPhase 3NCT00312195
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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) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Study details
- Official title
- An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
- Conditions
- Chronic Non-malignant Pain
- Interventions
- Drug: Buprenorphine transdermal patch
- Drug: Placebo to match BTDS
- Sponsor
- Purdue Pharma LP
- Collaborators
- Napp Pharmaceuticals Limited
- Start date
- 2001-03
- Primary completion
- 2001-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United Kingdom, United States
- Total sites listed
- 42
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy. * Good, very good or excellent pain control on current opioid therapy. * Willing and able to use a telephone interactive voice response service. Exclusion Criteria: * Currently receiving daily morphine or oxycodone monotherapy. * Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within 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/NCT00312195