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Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

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ClinicalTrials.gov Identifier: NCT01125917
Recruitment Status : Terminated (Terminated early due to administrative reasons.)
First Posted : May 19, 2010
Results First Posted : September 21, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Brief Summary:
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.

Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Drug: Buprenorphine transdermal patch 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
Study Start Date : June 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: BTDS
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Other Name: Butrans™

Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Other Name: Butrans™

Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Other Name: Butrans™




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 52-week extension phase ]
    The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).



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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:

  • Subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
  • For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

Exclusion Criteria:

  • Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

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): NCT01125917


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Sponsors and Collaborators
Purdue Pharma LP
Investigators
Study Director: Deborah L Steiner, MD, MS Purdue Pharma LP

Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01125917     History of Changes
Other Study ID Numbers: BUP3015S
First Posted: May 19, 2010    Key Record Dates
Results First Posted: September 21, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Purdue Pharma LP:
Low back pain
Opioid
Transdermal

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists