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

Chronic Nonmalignant Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151098
• Other study ID #: BUP3201S
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2010
• Last updated: September 5, 2012
• Start date: April 2001
• Est. completion date: February 2002

Study information

• Verified date: September 2012
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Nonmalignant Pain

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) as a Measure of Safety.	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.	28 weeks	Yes

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