Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Overview

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Full Title of Study: “A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2005

Detailed Description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Interventions

  • Drug: Buprenorphine transdermal patch
    • Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
  • Drug: Buprenorphine transdermal patch
    • Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Arms, Groups and Cohorts

  • Active Comparator: BTDS 5
    • Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
  • Experimental: BTDS 20
    • Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

Clinical Trial Outcome Measures

Primary Measures

  • The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
    • Time Frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
    • Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).

Participating in This Clinical Trial

Inclusion Criteria

  • osteoarthritis of the hip, knee, or spine for 1 year or longer. – taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. 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 conditions in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Purdue Pharma LP
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sarah O’Keefe, BSN, Study Chair, Purdue Pharma L.P., Stamford, CT

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