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

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315458

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: Buprenorphine transdermal patch Drug: Placebo transdermal patch	Phase III

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:	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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 483 days ] [ Designated as safety issue: Yes ]
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.

Enrollment:	107
Study Start Date:	December 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315458

Show 48 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:	Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier:	NCT00315458 History of Changes
Obsolete Identifiers:	NCT01137279
Other Study ID Numbers:	BUP3011 and BUP3011S
Study First Received:	April 17, 2006
Results First Received:	July 28, 2010
Last Updated:	December 2, 2010
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 February 12, 2012