Phase 3
Completed N=326
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Source: ClinicalTrials.gov NCT00313846 ↗Enrolled (actual)
326
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcomePrimary: The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. — 12.3; 17.2 days — p=.0026
Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. |
12.3; 17.2 | .0026 sig |
| SECONDARY Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site |
3.8; 3.2 | — |
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
Exclusion Criteria
- ingest opioid analgesics on a daily basis.
- ingest >2500 milligrams (mg) acetaminophen on a daily basis.
- require 80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00313846). 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.