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

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ClinicalTrials.gov Identifier: NCT00320801
Recruitment Status : Terminated (This study was terminated early due to administrative reasons.)
First Posted : May 3, 2006
Results First Posted : September 20, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Brief Summary:

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 or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine transdermal patch Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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™




Primary Outcome Measures :
  1. 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) ]
    Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320801


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

Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00320801     History of Changes
Obsolete Identifiers: NCT01137422
Other Study ID Numbers: BUP3014 and BUP3014S
First Posted: May 3, 2006    Key Record Dates
Results First Posted: September 20, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists