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Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

This study has been terminated.
(This study was terminated early for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01135524
First received: June 1, 2010
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.


Condition Intervention Phase
Osteoarthritis
 Drug: Buprenorphine transdermal patch
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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: 52 weeks ] [ 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: 196
Study Start Date: April 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (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 transdermally for 7-day wear.
Other Name: Butrans™
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.
Other Name: Butrans™
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.
Other Name: Butrans™

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.

Exclusion Criteria:

  • Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
  • Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135524

  Show 89 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
Product Information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01135524     History of Changes
Other Study ID Numbers: BUP3019S
Study First Received: June 1, 2010
Results First Received: July 15, 2010
Last Updated: September 5, 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
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013