Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
|ClinicalTrials.gov Identifier: NCT01633944|
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : February 3, 2016
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Buprenorphine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||752 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Placebo Comparator: Placebo
Twice Daily Dosing
Matching Placebo Buccal Film twice daily
Experimental: Buprenorphine HCl Buccal Film
Twice Daily Dosing
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
- Change From Baseline to Week 12 in Average Daily Pain Intensity Scores [ Time Frame: Baseline, Week 12 ]Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
- Number of Participants With Response to Treatment (Responder) Using NRS Scale [ Time Frame: Prior to open-label titration to Week 12 in double-blind treatment ]Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
- Number of Subjects With Rescue Medication Use [ Time Frame: Week 1 to Week 12 in double-blind treatment ]Use of analgesic rescue medication recorded in subject diary.
- Time to Optimal Dose of Open-label Study Medication [ Time Frame: Up to 8 weeks in open-label titration ]Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment.
- Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) [ Time Frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks) ]Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.
- Patient Global Impression of Change [ Time Frame: Week 12 ]Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)
- Change From Baseline to Week 12 in Roland Morris Disability Questionnaire [ Time Frame: Baseline, Week 12 ]Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
- Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale [ Time Frame: Baseline, Week 12 ]Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633944
|Study Director:||M. Todd Kirby, PhD||Endo Pharmaceuticals|