Phase 3
N=752
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01633944 ↗Enrolled (actual)
752
Serious AEs
0.7%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline to Week 12 in Average Daily Pain Intensity Scores — 0.94; 1.59 units on a scale — p=0.0012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioDelivery Sciences International
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Average Daily Pain Intensity Scores |
0.94; 1.59 | 0.0012 sig |
| SECONDARY Number of Participants With Response to Treatment (Responder) Using NRS Scale |
131; 99; 86; 69 | 0.0012 sig |
| SECONDARY Number of Subjects With Rescue Medication Use |
123; 140; 112; 132; 85; 107 | — |
| SECONDARY Time to Optimal Dose of Open-label Study Medication |
17.1 | — |
| SECONDARY Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
9.6; 14.2 | — |
| SECONDARY Patient Global Impression of Change |
4.5; 3.9 | — |
| SECONDARY Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
0.6; 1.2 | — |
| SECONDARY Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale |
-0.23; 0.10; -1.43; -1.68; 0.90; 0.14 | — |
Summary
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive 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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate to severe low back pain for ≥6 months
- Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
- Stable health, as determined by Principal Investigator
- Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
- Willing and able to comply with all protocol required visits and assessments
Exclusion Criteria
- Current cancer related pain or received chemotherapy with 6 months of screening
- Receiving opioid analgesic medication >10 mg MSE per day within 28 days of screening
- Subjects with a 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 to any opioid or acetaminophen
- Surgical procedure for relief of pain with 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
Data sourced from ClinicalTrials.gov (NCT01633944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.