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The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

NCT ID: NCT00315887

Last Updated: 2006-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

1999-10-31

Brief Summary

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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 and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) 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 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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine transdermal delivery system

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
* back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria

* receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
* scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Locations

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Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Arthritis Center of Connecticut

Waterbury, Connecticut, United States

Site Status

University Clinical Research

DeLand, Florida, United States

Site Status

Gainesville Clinical Research Center

Gainesville, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Sarasota Arthritis Center

Sarasota, Florida, United States

Site Status

Coastal Medical Research

South Daytona Beach, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Private Practice

Weston, Florida, United States

Site Status

Pain Management & Rehabilitation

Terre Haute, Indiana, United States

Site Status

Mid-America Rheumatology Consultants

Overland Park, Kansas, United States

Site Status

Riverhills Healthcare

Crestview Hills, Kentucky, United States

Site Status

Arthritis & Osteoporosis Treatment & Research Center

Jackson, Mississippi, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

PrecisionMed, Inc.

Las Vegas, Nevada, United States

Site Status

Cornerstone Research Care

High Point, North Carolina, United States

Site Status

Consultants for Clinical Research

Cincinnati, Ohio, United States

Site Status

Center for Clinical Research

Austin, Texas, United States

Site Status

The Arthritis Clinic of Northern Virginia

Arlington, Virginia, United States

Site Status

Evergreen Clinical Research

Edmonds, Washington, United States

Site Status

Private Practice

Wauwatosa, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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BP98-1201

Identifier Type: -

Identifier Source: org_study_id