Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Non-malignant Pain

In brief

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00312195

Run by

Purdue Pharma LP

People needed

267

Starts

2001-03-01

Expected to finish

2001-07-01

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…

• At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
• Good, very good or excellent pain control on current opioid therapy.
• Willing and able to use a telephone interactive voice response service.

You may not qualify if…

• Currently receiving daily morphine or oxycodone monotherapy.
• Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Hawthorne and York — Phoenix, Arizona, United States
• 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 and 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
• Private Practice — Chardon, Ohio, United States
• Summit Research Solutions — Memphis, Tennessee, United States
• Radiant Research — Austin, Texas, United States
• Wasatch Clinical Research — Salt Lake City, Utah, United States
• Clinical Research Management — New Berlin, Wisconsin, United States
• Whiteabbey Health Centre — Newtownabbey, Belfast, United Kingdom
• Antrim Coast Fundholding Group — Lame, Co Antrim, United Kingdom
• Portglenone Health Centre — Portglenone, CO Antrim, United Kingdom
• Garden Street Surgery — Magherafelt, Co Derry, United Kingdom

Full record on ClinicalTrials.gov

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