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

NCT ID: NCT00315445

Last Updated: 2012-09-03

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

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

1998-05-31

Brief Summary

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The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for 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.

Conditions

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Back Pain

Keywords

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chronic back pain 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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Placebo

Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20

Group Type PLACEBO_COMPARATOR

Placebo oxycodone/acetaminophen tablets

Intervention Type DRUG

Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

Placebo transdermal patch (TDS)

Intervention Type DRUG

Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

OXY/APAP

5 mg oxycodone/325 mg acetaminophen tablets

Group Type ACTIVE_COMPARATOR

OXY/APAP

Intervention Type DRUG

5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

BTDS

Buprenorphine transdermal patch 5, 10, or 20 mcg/hour

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.

Interventions

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Buprenorphine transdermal patch

Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.

Intervention Type DRUG

Placebo oxycodone/acetaminophen tablets

Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

Intervention Type DRUG

OXY/APAP

5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

Intervention Type DRUG

Placebo transdermal patch (TDS)

Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Intervention Type DRUG

Other Intervention Names

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Butrans™

Eligibility Criteria

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Inclusion Criteria

* clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion Criteria

* receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
* scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
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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Purdue Pharma L.P.

Locations

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Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Phoenix Center for Clinical Research

Phoenix, Arizona, United States

Site Status

Phoenix Orthopedic Center, Ltd.

Phoenix, Arizona, United States

Site Status

Gainesville Clinical Research Center

Gainesville, Florida, United States

Site Status

SeaView Research

Miami, Florida, United States

Site Status

Park Place Therapeutic Center

Plantation, Florida, United States

Site Status

Atlanta Research Center

Decatur, Georgia, United States

Site Status

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, United States

Site Status

New Jersey Research Foundation

Linwood, New Jersey, United States

Site Status

North Carolina Clinical Research, Inc.

Raleigh, North Carolina, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BP96-0604

Identifier Type: -

Identifier Source: org_study_id