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Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

NCT ID: NCT00490919

Last Updated: 2012-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

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 low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization 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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Low Back Pain

Keywords

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Chronic pain opioid transdermal Moderate to severe chronic low back pain

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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Double-blind BTDS 10 or 20

Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear

Group Type EXPERIMENTAL

Buprenorphine transdermal system

Intervention Type DRUG

Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days

Double-blind Placebo TDS

Placebo transdermal system to match BTDS patches, applied for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

transdermal system (placebo) worn for 7 days

Interventions

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Buprenorphine transdermal system

Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days

Intervention Type DRUG

Placebo

transdermal system (placebo) worn for 7 days

Intervention Type DRUG

Other Intervention Names

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Butrans™

Eligibility Criteria

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Inclusion Criteria

* Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
* 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 low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria

* Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
* Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
* Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Minimum Eligible Age

18 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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Research Facility

Anniston, Alabama, United States

Site Status

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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Research Facility

Phoenix, Arizona, United States

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Research Facility

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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Research Facility

Carmichael, California, United States

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Advance Care Medical Group

City of Industry, California, United States

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Research Facility

Downey, California, United States

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Foothill Ranch, California, United States

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Sacramento, California, United States

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San Luis Obispo, California, United States

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Littleton, Colorado, United States

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Stamford, Connecticut, United States

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Clinical Research of West Florida

Clearwater, Florida, United States

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Research Facility

Clearwater, Florida, United States

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University Clinical Research

DeLand, Florida, United States

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Arthritis Associates of S. FL

Delray Beach, Florida, United States

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Research Facility

Fort Myers, Florida, United States

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Century Clinical Research, Inc.

Holly Hill, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Merritt Island, Florida, United States

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Pharmax Research Clinic

Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Port Orange, 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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West Palm Beach, Florida, United States

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Independent Neurodiagnostic Clinic

Atlanta, Georgia, United States

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Dawsonville, Georgia, United States

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Druid Oaks Health Center

Decatur, Georgia, United States

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Marietta, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, 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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CTT Consultants, Inc.

Prairie Village, Kansas, United States

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Dolby Research, LLC

Baton Rouge, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, 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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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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Research Facility

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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Las Vegas, Nevada, United States

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Lovelace Scientific Resources

Albuquerque, New Mexico, 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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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Morgantown, North Carolina, United States

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Cincinnati, Ohio, United States

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Community Research

Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, 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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Altoona, Pennsylvania, United States

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Chicora, Pennsylvania, United States

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Duncansville, 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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Anderson Family Care, PA

Anderson, South Carolina, United States

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KRK Medical Research

Dallas, Texas, United States

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Killeen, Texas, United States

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Plano, 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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Roanoke, Virginia, United States

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Countries

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United States

References

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Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011 Dec;42(6):903-17. doi: 10.1016/j.jpainsymman.2011.04.006. Epub 2011 Sep 25.

Reference Type RESULT
PMID: 21945130 (View on PubMed)

Other Identifiers

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BUP3024

Identifier Type: -

Identifier Source: org_study_id