Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain - Full Text View

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00312572

Purpose

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Condition	Intervention	Phase
Osteoarthritis	Drug: Buprenorphine 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:	A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Vicodin

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

The Percentage of Subjects Who Completed the 14-day Double-blind Phase. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).

Enrollment:	204
Study Start Date:	June 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BTDS10/20 Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.	Drug: Buprenorphine transdermal patch Buprenorphine transdermal patch applied for 7-day wear. Other Name: Butrans™
Experimental: BTDS 20 Initial doses (Level 1) of BTDS 20.	Drug: Buprenorphine transdermal patch Buprenorphine transdermal patch 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 to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Exclusion Criteria:

currently have condition requiring a stable regimen of acetaminophen (APAP).
a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312572

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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:	NCT00312572 History of Changes
Other Study ID Numbers:	BUP3018
Study First Received:	April 7, 2006
Results First Received:	July 29, 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