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Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back 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: NCT00490919
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : September 9, 2010
Last Update Posted : September 10, 2012
Information provided by (Responsible Party):
Purdue Pharma LP

Brief Summary:
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Buprenorphine transdermal system Drug: Placebo 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 539 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
Study Start Date : June 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Double-blind BTDS 10 or 20
Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal system
Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
Other Name: Butrans™

Placebo Comparator: Double-blind Placebo TDS
Placebo transdermal system to match BTDS patches, applied for 7 days
Drug: Placebo
transdermal system (placebo) worn for 7 days

Primary Outcome Measures :
  1. Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. [ Time Frame: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase. ]
    Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.

Secondary Outcome Measures :
  1. The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase [ Time Frame: weeks 2-12 ]
    Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.

  2. The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, 12 of double-blind phase ]
    The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

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:

  • Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
  • Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
  • Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria:

  • Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
  • Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
  • Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion 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): NCT00490919

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Sponsors and Collaborators
Purdue Pharma LP
Additional Information:
Publications of Results:
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Responsible Party: Purdue Pharma LP Identifier: NCT00490919    
Other Study ID Numbers: BUP3024
First Posted: June 25, 2007    Key Record Dates
Results First Posted: September 9, 2010
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Purdue Pharma LP:
Chronic pain
Moderate to severe chronic low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists