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
Overview
- Phase
- Phase 3
- Intervention
- Buprenorphine transdermal patch
- Conditions
- Chronic Non-malignant Pain
- Sponsor
- Purdue Pharma LP
- Enrollment
- 267
- Locations
- 41
- Primary Endpoint
- The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
BTDS (5, 10 or 20)
Buprenorphine transdermal patch
Intervention: Buprenorphine transdermal patch
Placebo to match BTDS
Placebo to match buprenorphine transdermal patch
Intervention: Placebo to match BTDS
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment(14 days)
- 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)
- The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).(14 days)