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

Phase 3

Completed

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
BTDS 5, 10 or 20	Buprenorphine transdermal patch	Buprenorphine transdermal patch

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) as a Measure of Safety.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (19): University Clinical Research Deland
🇺🇸
Deland, Florida, United States
Pain Management & Rehabilitation
🇺🇸
Terre Haute, Indiana, United States
Arizona Research Center Inc.
🇺🇸
Phoenix, Arizona, United States
Tampa Bay Medical Research Inc
🇺🇸
Clearwater, Florida, United States
Gold Coast Research, LLC
🇺🇸
Plantation, Florida, United States
Clinical Research Consultants Inc
🇺🇸
Trumbull, Connecticut, United States
University Clinical Research Inc,
🇺🇸
Pembroke Pines, Florida, United States
Family Medicine Associates
🇺🇸
Evansville, Indiana, United States
Southeastern Center for Headache and Pain
🇺🇸
Crestview Heights, Kentucky, United States
Gold Coast Research LLC
🇺🇸
Tamarac, Florida, United States
Westside Family Medical Center PC
🇺🇸
Kalamazoo, Michigan, United States
ALL-TRIALS Clinical Research LLC
🇺🇸
Winston-Salem, North Carolina, United States
Radiant Research - Austin
🇺🇸
Austin, Texas, United States
Summit Research Solutions
🇺🇸
Memphis, Tennessee, United States
Wasatch Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Clinical Research of South Florida
🇺🇸
Coral Gables, Florida, United States
Cornerstone Research Care
🇺🇸
High Point, North Carolina, United States
The Arthritis Clinic
🇺🇸
Charlotte, North Carolina, United States
Clinical Research Management
🇺🇸
New Berlin, Wisconsin, United States