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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01151098
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 23, 2010
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Nonmalignant Pain Drug: Buprenorphine transdermal patch Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.
Study Start Date : April 2001
Primary Completion Date : February 2002
Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BTDS 5, 10 or 20
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear
Other Name: Butrans™


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) as a Measure of Safety. [ Time Frame: 28 weeks ]
    Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151098


Locations
United States, Arizona
Arizona Research Center Inc.
Phoenix, Arizona, United States, 85023
United States, Connecticut
Clinical Research Consultants Inc
Trumbull, Connecticut, United States, 06611
United States, Florida
Tampa Bay Medical Research Inc
Clearwater, Florida, United States, 33761
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
University Clinical Research Deland
Deland, Florida, United States, 32720
University Clinical Research Inc,
Pembroke Pines, Florida, United States, 33024
Gold Coast Research, LLC
Plantation, Florida, United States, 33324
Gold Coast Research LLC
Tamarac, Florida, United States, 33321
United States, Indiana
Family Medicine Associates
Evansville, Indiana, United States, 47712
Pain Management & Rehabilitation
Terre Haute, Indiana, United States, 47807
United States, Kentucky
Southeastern Center for Headache and Pain
Crestview Heights, Kentucky, United States, 41017
United States, Michigan
Westside Family Medical Center PC
Kalamazoo, Michigan, United States, 49009
United States, North Carolina
The Arthritis Clinic
Charlotte, North Carolina, United States, 28211
Cornerstone Research Care
High Point, North Carolina, United States, 27262
ALL-TRIALS Clinical Research LLC
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Summit Research Solutions
Memphis, Tennessee, United States, 38119
United States, Texas
Radiant Research - Austin
Austin, Texas, United States, 78758
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
Clinical Research Management
New Berlin, Wisconsin, United States, 53151
Sponsors and Collaborators
Purdue Pharma LP
More Information

Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01151098     History of Changes
Other Study ID Numbers: BUP3201S
First Posted: June 25, 2010    Key Record Dates
Results First Posted: September 23, 2010
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Purdue Pharma LP:
Chronic nonmalignant pain
Opioid
Transdermal
Butrans (BTDS)

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists