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Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

This study has been completed.
Information provided by (Responsible Party):
Purdue Pharma LP Identifier:
First received: June 2, 2010
Last updated: August 27, 2012
Last verified: August 2012
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Condition Intervention Phase
Drug: Buprenorphine transdermal patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Resource links provided by NLM:

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months. ]
    Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Enrollment: 290
Study Start Date: April 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTDS
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

  • Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
  • Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01141283

  Show 42 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
Responsible Party: Purdue Pharma LP Identifier: NCT01141283     History of Changes
Other Study ID Numbers: BUP3012S
Study First Received: June 2, 2010
Results First Received: July 28, 2010
Last Updated: August 27, 2012

Keywords provided by Purdue Pharma LP:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on May 22, 2017