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Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

NCT ID: NCT00531427

Last Updated: 2012-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

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The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Detailed Description

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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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Conditions

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Chronic Pain Osteoarthritis of the Knee

Keywords

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Chronic pain, OA of the knee, opioid, transdermal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Buprenorphine transdermal system 10 and 20 applied for 7-day wear

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

transdermal system 10 and 20 applied for 7-day wear

2

Placebo transdermal system to match BTDS patches, applied for 7-day wear

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

transdermal system (placebo) applied for 7-day wear

Interventions

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Buprenorphine

transdermal system 10 and 20 applied for 7-day wear

Intervention Type DRUG

Placebo

transdermal system (placebo) applied for 7-day wear

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
* clinical diagnosis of OA of the knee 1 year or longer,
* subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \< 5 mg oxycodone (or equivalent) per day,
* subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria

* subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
* subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
* subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Coastal Clinical Research, Inc.

Mobile, Alabama, United States

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Radiant Research, Phoenix Southeast

Chandler, Arizona, United States

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Arizona Research Center, Inc.

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Lovelace Scientific Resources, Inc.

Beverly Hills, California, United States

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Catalina Research Institute

Chino, California, United States

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Downey, California, United States

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Foothill Ranch, California, United States

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Laguna Hills, California, United States

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Sacramento, California, United States

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Littleton, Colorado, United States

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Stamford, Connecticut, United States

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Coastal Pain Management

Bradenton, Florida, United States

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Clinical Research of West Florida

Clearwater, Florida, United States

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Clearwater, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Pharmax Research Clinic

Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Royal Palm Hammock, Florida, United States

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Clinical Research of West Flor

Tampa, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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AMR Research Associates

Bogart, Georgia, United States

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Dawsonville, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Rehabilitation Association of IN

Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Graves-Gilbert Clinic

Bowling Green, Kentucky, United States

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Stat-Lab I, Inc.

Baton Rouge, Louisiana, United States

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New Iberia, Louisiana, United States

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New Orleans, Louisiana, United States

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Frederick, Maryland, United States

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Brockton, Massachusetts, United States

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East Coast Clinical Research

Haverhill, Massachusetts, United States

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Springfield, Massachusetts, United States

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Bay City, Michigan, United States

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Premier Internal Medicine

Biloxi, Mississippi, United States

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Florissant, Missouri, United States

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St Louis, Missouri, United States

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Sports Med Consultants PC

St Louis, Missouri, United States

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Henderson, Nevada, United States

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New York, New York, United States

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New York, New York, United States

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Morgantown, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Digestive Endoscopy Center

Dayton, Ohio, United States

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Dayton, Ohio, United States

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Middleburg Heights, Ohio, United States

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Mount Gilead, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Paramount Clinical Research

Bridgeville, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Oyster Point Family Health Ctr

Lancaster, Pennsylvania, United States

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Mechanicsburg, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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New England Center for Clinical Research

Cranston, Rhode Island, United States

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Cranston, Rhode Island, United States

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Greenville Pharmaceutical Research

Greenville, South Carolina, United States

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Arthritis Clinic, PLLC

Jackson, Tennessee, United States

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Austin, Texas, United States

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Colleyville, Texas, United States

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Dallas, Texas, United States

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Nederland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Salt Lake City, Utah, United States

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NDC Medical Center

Norfolk, Virginia, United States

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Independence Family Medicine

Virginia Beach, Virginia, United States

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Pacific Northwest Primary Care

Tacoma, Washington, United States

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Countries

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United States

Other Identifiers

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BUP3025

Identifier Type: -

Identifier Source: org_study_id