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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312195
Recruitment Status : Completed
First Posted : April 7, 2006
Results First Posted : October 15, 2010
Last Update Posted : September 10, 2012
Napp Pharmaceuticals Limited
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Non-malignant Pain Drug: Buprenorphine transdermal patch Drug: Placebo to match BTDS Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2001
Actual Primary Completion Date : July 2001
Actual Study Completion Date : July 2001

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312195

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Sponsors and Collaborators
Purdue Pharma LP
Napp Pharmaceuticals Limited
Additional Information:
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Responsible Party: Purdue Pharma LP Identifier: NCT00312195    
Other Study ID Numbers: BUP3201
First Posted: April 7, 2006    Key Record Dates
Results First Posted: October 15, 2010
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Purdue Pharma LP:
Chronic pain
Butrans™ [BTDS]
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists