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

Phase 3

Completed

• Conditions: Chronic Non-malignant Pain
• Interventions: Drug: Buprenorphine transdermal patch; 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.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-06
• Study First Posted: 2006-04-07
• Results First Submitted: 2010-07-29
• Results First Submitted QC: 2010-09-28
• Results First Posted: 2010-10-15
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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.

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)

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; 🇺🇸 Tamarac, Florida, United States

Family Medicine Associates; 🇺🇸 Evansville, Indiana, United States

Pain Management and Rehabilitation; 🇺🇸 Terre Haute, Indiana, United States

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