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

This study has been terminated.
(This study was terminated early due to administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00320801
First received: April 28, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Buprenorphine transdermal patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome 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) ] [ Designated as safety issue: Yes ]
    Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).


Enrollment: 188
Study Start Date: January 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Name: Butrans™
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied 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:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320801

  Show 66 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
Investigators
Study Chair: Sarah O'Keefe, BSN Purdue Pharma L.P., Stamford, CT
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00320801     History of Changes
Obsolete Identifiers: NCT01137422
Other Study ID Numbers: BUP3014 and BUP3014S
Study First Received: April 28, 2006
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:
Chronic pain
osteoarthritis
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 April 17, 2014