Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
- Conditions
- Chronic Non-malignant Pain
- Interventions
- Drug: Placebo to match BTDS
- Registration Number
- NCT00312195
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
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.
- Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS (5, 10 or 20) Buprenorphine transdermal patch Buprenorphine transdermal patch Placebo to match BTDS Placebo to match BTDS Placebo to match buprenorphine transdermal patch
- Primary Outcome Measures
Name Time Method The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. Double-blind phase (14 days) Ineffective treatment was defined as:
* Subject took \>1 gram of acetaminophen in a 24-hour period, or
* Subject required a change in transdermal patch (TDS) dose, or
* Subject had difficulty in keeping the TDS on, or
* Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).
Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
- Secondary Outcome Measures
Name Time Method Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment 14 days The time of ineffective treatment was calculated as the earliest of the following:
* The date the subject first took \>1 gram of acetaminophen,
* The visit date when ineffective treatment was first determined, or
* The date the last patch was removed.The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase 14 days Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). 14 days The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
Trial Locations
- Locations (41)
Clinical Research Consultants Inc
🇺🇸Trumbull, Connecticut, United States
Houston Surgery
🇬🇧Houston, Renfrewshire, United Kingdom
Gables Medical Section
🇬🇧Coventry, Warwickshire, United Kingdom
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Hawthorne and York
🇺🇸Phoenix, Arizona, United States
Arizona Research Center Inc
🇺🇸Phoenix, Arizona, United States
University Clinical Research Inc,
🇺🇸Pembroke Pines, Florida, United States
Westside Family Medical Center PC
🇺🇸Kalamazoo, Michigan, United States
Tampa Bay Medical Research Inc
🇺🇸Clearwater, Florida, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
The Arthritis Clinic
🇺🇸Charlotte, North Carolina, United States
Bennett Road Surgery
🇬🇧Keresley End, Coventry, United Kingdom
Leslie Surgery
🇬🇧Glenrothes, Fife, United Kingdom
Springhill Surgery
🇬🇧Bangor, Co Down, United Kingdom
Little Common Surgery
🇬🇧Bexhill-on-Sea, E Sussex, United Kingdom
Private Practice
🇺🇸Chardon, Ohio, United States
Antrim Coast Fundholding Group
🇬🇧Lame, Co Antrim, United Kingdom
Summit Research Solutions
🇺🇸Memphis, Tennessee, United States
Whiteabbey Health Centre
🇬🇧Newtownabbey, Belfast, United Kingdom
Clinical Research Management
🇺🇸New Berlin, Wisconsin, United States
Old Town Surgery
🇬🇧Bexhill-on-Sea, E Sussex, United Kingdom
Roebuck House Surgery
🇬🇧Hastings, E Sussex, United Kingdom
Valleyfield Health Centre
🇬🇧High Valleyfield, Fife, United Kingdom
Grosvenor Medical Centre
🇬🇧Tunbridge Wells, W Sussex, United Kingdom
The Ridge Medical Practice, Great Horton
🇬🇧Bradford, West Yorkshire, United Kingdom
Townhead Health Centre
🇬🇧Glasgow, United Kingdom
Castlemilk Health Centre
🇬🇧Glasgow, United Kingdom
University Clinical Research Deland
🇺🇸Deland, Florida, United States
ALL-TRIALS Clinical Research LLC
🇺🇸Winston-Salem, North Carolina, United States
Southeastern Center for Headache and Pain
🇺🇸Crestview Heights, Kentucky, United States
Family Medicine Associates
🇺🇸Evansville, Indiana, United States
Pain Management and Rehabilitation
🇺🇸Terre Haute, Indiana, United States
Gold Coast Research LLC
🇺🇸Tamarac, Florida, United States
Garden Street Surgery
🇬🇧Magherafelt, Co Derry, United Kingdom
Cornerstone Research Care
🇺🇸High Point, North Carolina, United States
Portglenone Health Centre
🇬🇧Portglenone, CO Antrim, United Kingdom
Ashvale Health Centre
🇬🇧Aldershot, Hants, United Kingdom
The Academy Medical Practice
🇬🇧Coatbridge, Lanarkshire, United Kingdom
The Burns Practice
🇬🇧Doncaster, S Yorkshire, United Kingdom
Sanbury Health Centre Group Practice
🇬🇧Sunbury-on-Thames, Middx, United Kingdom
Radiant Research
🇺🇸Austin, Texas, United States