Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
- Registration Number
- NCT01675167
- Lead Sponsor
- BioDelivery Sciences International
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815
- Diagnosis of moderate to severe low back pain for ≥6 months
- Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
- Stable health, as determine by Principal Investigator
- Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
- Willing and able to comply with all protocol required visits and assessments
- Current cancer related pain or received chemotherapy within 6 months of screening
- Subjects with history of other chronic painful conditions
- Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Allergy or contraindications of any opioid or acetaminophen
- Surgical procedure for relief of pain within 6 months
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome or a family member with this condition
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Current or past history of alcohol abuse
- Positive urine toxicology screen for drug of abuse
- History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Buccal Film Placebo Twice Daily Dosing Buprenorphine HCl Buccal Film Buprenorphine Twice Daily Dosing
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Average Daily Pain Intensity Scores 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).
- Secondary Outcome Measures
Name Time Method Number of Participants With Response to Treatment (Responder) Using NRS Scale 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 numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Number of Subjects With Opioid Rescue Medication Use Week 1 to Week 12 Use of analgesic rescue medication recorded in subject diary
Time to Optimal Dose of Open-label Study Medication Up to 8 weeks in open-label titration Overall time to reach the "optimum" 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) 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 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 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 Outcome Score Sleep Subscale 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).
Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep 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 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.
Trial Locations
- Locations (66)
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
Scroll for more (56 remaining)Parkway Medical Center🇺🇸Birmingham, Alabama, United States