Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
|Chronic Non-malignant Pain||Drug: Buprenorphine transdermal patch Drug: Placebo to match BTDS||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes|
- The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. [ Time Frame: 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.
- Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 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.
|Study Start Date:||March 2001|
|Study Completion Date:||July 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
Experimental: BTDS (5, 10 or 20)
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo to match BTDS
Placebo to match buprenorphine transdermal patch
Drug: Placebo to match BTDS
Placebo to match buprenorphine transdermal patch applied for 7-day wear.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312195
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