Phase 3
Completed N=204
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Source: ClinicalTrials.gov NCT00312572 ↗Enrolled (actual)
204
Serious AEs
1.1%
Results posted
Sep 2010
Primary outcomePrimary: The Percentage of Subjects Who Completed the 14-day Double-blind Phase. — 88; 83; 85; 85 Percentage of Participants
Summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Who Completed the 14-day Double-blind Phase. |
88; 83; 85; 85; 79; 82 | — |
Eligibility Criteria
Inclusion Criteria
- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
Exclusion Criteria
- currently have condition requiring a stable regimen of acetaminophen (APAP).
- a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00312572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.