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

This study has been completed.
Sponsor:
Collaborator:
Napp Pharmaceuticals Limited
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00312195
First received: April 5, 2006
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Chronic Non-malignant Pain
Drug: Buprenorphine transdermal patch
Drug: Placebo to match BTDS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. [ Time Frame: Double-blind phase (14 days) ] [ Designated as safety issue: No ]

    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:
  • Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 267
Study Start Date: March 2001
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312195

  Show 42 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
Napp Pharmaceuticals Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312195     History of Changes
Other Study ID Numbers: BUP3201
Study First Received: April 5, 2006
Results First Received: July 29, 2010
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Chronic pain
opioid
transdermal
Butrans™ [BTDS]

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014