Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System in Subjects With Osteoarthritis - Full Text View

Sponsored by:	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 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 delivery system	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Vicodin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Completion of the 14-day double-blind phase.

Secondary Outcome Measures:

Proportion of days a subject had successful analgesia
rate of premature discontinuation
mean daily average pain over last 24 hours score
WOMAC Osteoarthritis Index score
Medical Outcome Study Sleep Scale score
and treatment satisfaction survey

Estimated Enrollment:	200
Study Start Date:	June 2003
Estimated Study Completion Date:	July 2004

Detailed Description:

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

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 OA pain.

Exclusion Criteria:

currently have condition requiring a stable regimen of 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

Show 36 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Study ID Numbers:	BUP3018
Study First Received:	April 7, 2006
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00312572
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Osteoarthritis, opioid, transdermal

Study placed in the following topic categories:

Buprenorphine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009