Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
TerminatedPhase 3NCT00313014
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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 (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.
Study details
- Official title
- A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
- Conditions
- Interventions
- Drug: Buprenorphine
- Drug: Buprenorphine
- Drug: Oxycodone Immediate-Release
- Sponsor
- Purdue Pharma LP
- Start date
- 2004-02
- Primary completion
- 2005-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 85
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * low back pain for 3 months or longer, confirmed by radiographic evidence. * receiving a stable dose of an opioid analgesic for low back pain. Exclusion Criteria: * taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. * requiring frequent analgesic therapy for chronic condition(s), in addition to low back 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/NCT00313014