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.
Sponsor:
Purdue Pharma LP
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01141283
First received: June 2, 2010
Last updated: August 27, 2012
Last verified: August 2012
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Purpose
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Buprenorphine transdermal patch |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study 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. ] [ Designated as safety issue: Yes ]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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier: NCT01141283
Show 42 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141283
Show 42 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
More Information
Additional Information:
| Responsible Party: | Purdue Pharma LP |
| ClinicalTrials.gov 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 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
Osteoarthritis Opioid Transdermal |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |
ClinicalTrials.gov processed this record on September 29, 2016