Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00490919|
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : September 9, 2010
Last Update Posted : September 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Buprenorphine transdermal system Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||539 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
transdermal system (placebo) worn for 7 days
- 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.
- 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.
- 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.
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): NCT00490919