Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain. - Full Text View

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

Purpose

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (immediate release oxycodone) will be provided to all subjects in addition to study drug.

Condition	Intervention	Phase
Osteoarthritis	Drug: Buprenorphine transdermal delivery system	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Mod-to-Sev 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:

The time from first application of double-blind treatment to the development of inadequate analgesia at the primary OA pain site.

Secondary Outcome Measures:

Pain Right Now score

Estimated Enrollment:	310
Study Start Date:	December 2003
Estimated Study Completion Date:	February 2005

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 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

No publications provided

Study ID Numbers:	BUP3011
Study First Received:	April 17, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00315458 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

osteoarthritis
opioid
transdermal

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Buprenorphine

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 05, 2009