Phase 3
Completed N=815
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
Source: ClinicalTrials.gov NCT01675167 ↗Enrolled (actual)
815
Serious AEs
1.7%
Results posted
Feb 2016
Primary outcomePrimary: Change From Baseline to Week 12 in Average Daily Pain Intensity Scores — 0.88; 1.92 units on a scale — p=<.00001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Average Daily Pain Intensity Scores |
0.88; 1.92 | <.00001 sig |
| SECONDARY Number of Participants With Response to Treatment (Responder) Using NRS Scale |
156; 76; 96; 42 | <.0001 sig |
| SECONDARY Number of Subjects With Opioid Rescue Medication Use |
215; 228; 202; 185; 197; 172 | — |
| SECONDARY Time to Optimal Dose of Open-label Study Medication |
24.5 | — |
| SECONDARY Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
9.9; 29.4 | — |
| SECONDARY Patient Global Impression of Change |
4.5; 3.2 | — |
| SECONDARY Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
0.5; 1.6 | — |
| SECONDARY Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale |
-0.36; -1.37; -0.93; -3.54; 0.20; -0.38 | — |
| SECONDARY Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep |
75; 81; 156; 149 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01675167). 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. Informational only — not medical advice.