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Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

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ClinicalTrials.gov Identifier: NCT00315458
Recruitment Status : Terminated (Administrative reasons.)
First Posted : April 18, 2006
Results First Posted : September 23, 2010
Last Update Posted : September 3, 2012
Information provided by (Responsible Party):
Purdue Pharma LP

Brief Summary:
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine transdermal patch Drug: Placebo 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 : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
Study Start Date : December 2003
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BTDS
Buprenorphine transdermal patches 10 or 20 mcg/h
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
Drug: Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 483 days ]
    For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
  • taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

  • requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
  • scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

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): NCT00315458

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Sponsors and Collaborators
Purdue Pharma LP

Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00315458     History of Changes
Obsolete Identifiers: NCT01137279
Other Study ID Numbers: BUP3011 and BUP3011S
First Posted: April 18, 2006    Key Record Dates
Results First Posted: September 23, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Purdue Pharma LP:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists