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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Buprenorphine transdermal patch

• Registration Number: NCT01141283
• Lead Sponsor: Purdue Pharma LP

Brief Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Results First Submitted: 2010-07-28
• Results First Submitted QC: 2010-08-24
• Results First Posted: 2010-09-21
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BTDS	Buprenorphine transdermal patch	Buprenorphine transdermal patch

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability	6 months.	Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Trial Locations

Locations (21)

Vista Medical Research Inc.; 🇺🇸 Mesa, Arizona, United States

Arthrocare, Arthritis Care and Research; 🇺🇸 Phoenix, Arizona, United States

Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Research Facility; 🇺🇸 Bellevue, Washington, United States

Advanced Pain Medicine; 🇺🇸 Bakersfield, California, United States

Orange County Clinical Research; 🇺🇸 Cypress, California, United States

San Diego Arthritis & Osteoporosis Medical Clinic; 🇺🇸 San Diego, California, United States

Allergy, Asthma, Arthritis & Lung; 🇺🇸 Daytona Beach, Florida, United States

University Clinical Research Deland; 🇺🇸 Deland, Florida, United States

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