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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

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ClinicalTrials.gov Identifier: NCT00313014
Recruitment Status : Terminated (Terminated early due to administrative reasons unrelated to efficacy or safety.)
First Posted : April 11, 2006
Results First Posted : September 29, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Description
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Brief Summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Drug: Buprenorphine Drug: Oxycodone Immediate-Release 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
Study Start Date : February 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
 Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Other Name: Butrans™
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
 Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Name: Butrans™
Experimental: Oxycodone Immediate-Release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
 Drug: Oxycodone Immediate-Release
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).


Outcome Measures
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Primary Outcome Measures :
  1. Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. [ Time Frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase ]
    Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)


Secondary Outcome Measures :
  1. Mean Daily Number of Supplemental Analgesic Tablets [ Time Frame: Double-blind phase (84 days) ]
    The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase

  2. Oswestry Disability Index (ODI) Score (V 2.0) [ Time Frame: Weeks 4, 8, 12 ]

    The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.

    The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)


  3. The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. [ Time Frame: Weeks 4, 8, 12 of the double-blind phase ]

    The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).

    Question 1 is scored on a scale of 1 to 5 and Questions 3 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.



Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • low back pain for 3 months or longer, confirmed by radiographic evidence.
  • receiving a stable dose of an opioid analgesic for low back pain.

Exclusion Criteria:

  • taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
  • requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00313014


Locations
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Sponsors and Collaborators
Purdue Pharma LP
Investigators
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Principal Investigator: Martin Hale, MD Gold Coast Research LLC, Weston, FL, USA
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00313014    
Other Study ID Numbers: BUP3015
First Posted: April 11, 2006    Key Record Dates
Results First Posted: September 29, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Purdue Pharma LP:
Low back pain
opioid
transdermal
Butrans
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Oxycodone
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists