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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00490919 |
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Date of registration:
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21/06/2007 |
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Primary sponsor: |
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Public title:
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Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
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Scientific title:
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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 |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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539 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00490919 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Drug: Buprenorphine transdermal system
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Drug: Placebo
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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