Clinical trial NCT01151098: Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Nonmalignant Pain
Keywords: Chronic nonmalignant pain
Opioid
Transdermal
Butrans (BTDS)
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety.
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center Inc.
state: Arizona
city: Trumbull
country: United States
facility: Clinical Research Consultants Inc
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Inc,
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Tamarac
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Evansville
country: United States
facility: Family Medicine Associates
state: Indiana
city: Terre Haute
country: United States
facility: Pain Management & Rehabilitation
state: Indiana
city: Crestview Heights
country: United States
facility: Southeastern Center for Headache and Pain
state: Kentucky
city: Kalamazoo
country: United States
facility: Westside Family Medical Center PC
state: Michigan
city: Charlotte
country: United States
facility: The Arthritis Clinic
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Winston-Salem
country: United States
facility: ALL-TRIALS Clinical Research LLC
state: North Carolina
city: Memphis
country: United States
facility: Summit Research Solutions
state: Tennessee
city: Austin
country: United States
facility: Radiant Research - Austin
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: New Berlin
country: United States
facility: Clinical Research Management
state: Wisconsin
Study officials:
References: