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

Completed · Phase 3

Conditions studied: Chronic Nonmalignant Pain

In brief

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.

Key facts

Study ID

NCT01151098

Run by

Purdue Pharma LP

People needed

189

Starts

2001-04-01

Expected to finish

2002-02-01

Last updated by the study team

2012-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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