The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
815
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
Matching Placebo Buccal Film twice daily
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
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).
Time frame: Baseline, week 12
Number of Participants With Response to Treatment (Responder) Using NRS Scale
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 numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Prior to open-label titration to week 12 in double-blind treatment
Number of Subjects With Opioid Rescue Medication Use
Use of analgesic rescue medication recorded in subject diary
Time frame: Week 1 to Week 12
Time to Optimal Dose of Open-label Study Medication
Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment
Time frame: Up to 8 weeks in open-label titration
Percentage of Participants With Treatment Failure in the 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.
Time frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Patient Global Impression of Change
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Parkway Medical Center
Birmingham, Alabama, United States
Haleyville Clinical Research LLC
Haleyville, Alabama, United States
Horizon Research Group. Inc / Alabama Orthopedice
Mobile, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Global Research
Anaheim, California, United States
Catalina Research Institute, LLC
Chino, California, United States
Synergy Clinical Research Center of Escondido
Escondido, California, United States
RX Clinical Research, Inc.
Garden Grove, California, United States
Adam D. Karns, MD
Los Angeles, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
...and 56 more locations
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)
Time frame: Week 12
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
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.
Time frame: Baseline, week 12
Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale
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).
Time frame: Baseline, Week 12
Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep
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 quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.
Time frame: Week 12