Phase 3 N=326 Randomized Double-blind Treatment

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00313846 ↗

Enrolled (actual)

326

Serious AEs

0.8%

Results posted

Sep 2010

Primary outcome: 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 days — p=.0026

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Buprenorphine transdermal patch (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Purdue Pharma LP
Primary completion: Jun 2004

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.