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Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

NCT ID: NCT01151098

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

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2002-02-28

Brief Summary

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The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Detailed Description

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Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Conditions

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Chronic Nonmalignant Pain

Keywords

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Chronic nonmalignant pain Opioid Transdermal Butrans (BTDS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BTDS 5, 10 or 20

Buprenorphine transdermal patch

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Interventions

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Buprenorphine transdermal patch

Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Intervention Type DRUG

Other Intervention Names

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Butrans™

Eligibility Criteria

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Inclusion Criteria

Include:

* Subjects of either sex aged 18 years or older.
* Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.

Exclusion Criteria

Include:

* Subjects currently receiving daily morphine or oxycodone (mono-therapy).
* Subjects who are discontinued from BUP3201 due to adverse events.
* Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.

Refer to core study for additional inclusion/exclusion information.
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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Arizona Research Center Inc.

Phoenix, Arizona, United States

Site Status

Clinical Research Consultants Inc

Trumbull, Connecticut, United States

Site Status

Tampa Bay Medical Research Inc

Clearwater, Florida, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

University Clinical Research Deland

DeLand, Florida, United States

Site Status

University Clinical Research Inc,

Pembroke Pines, Florida, United States

Site Status

Gold Coast Research, LLC

Plantation, Florida, United States

Site Status

Gold Coast Research LLC

Tamarac, Florida, United States

Site Status

Family Medicine Associates

Evansville, Indiana, United States

Site Status

Pain Management & Rehabilitation

Terre Haute, Indiana, United States

Site Status

Southeastern Center for Headache and Pain

Crestview Heights, Kentucky, United States

Site Status

Westside Family Medical Center PC

Kalamazoo, Michigan, United States

Site Status

The Arthritis Clinic

Charlotte, North Carolina, United States

Site Status

Cornerstone Research Care

High Point, North Carolina, United States

Site Status

ALL-TRIALS Clinical Research LLC

Winston-Salem, North Carolina, United States

Site Status

Summit Research Solutions

Memphis, Tennessee, United States

Site Status

Radiant Research - Austin

Austin, Texas, United States

Site Status

Wasatch Clinical Research

Salt Lake City, Utah, United States

Site Status

Clinical Research Management

New Berlin, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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BUP3201S

Identifier Type: -

Identifier Source: org_study_id