Phase 3
Completed N=334
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Source: ClinicalTrials.gov NCT01256450 ↗Enrolled (actual)
334
Serious AEs
0.4%
Results posted
Dec 2015
Primary outcomePrimary: Change in Pain Intensity From Baseline to Week 12 — 0.33; 0.46 units on a scale — p=.5870
Summary
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity From Baseline to Week 12 |
0.33; 0.46 | .5870 |
| SECONDARY Change From Baseline in Pain Intensity Over Time Using NRS Scale |
0.21; 0.25; 0.20; 0.29; 0.13; 0.25 | — |
| SECONDARY Number of Participants With Response to Treatment as Assessed by an NRS Scale |
117; 118; 48; 32; 37; 30 | — |
| SECONDARY Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) |
9.4; 11.9 | — |
| SECONDARY Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale |
-0.32; -0.92 | — |
| SECONDARY Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM |
-2.06; -9.03; 3.09; 10.88; -3.12; -0.00 | — |
| SECONDARY Change From Baseline to Week 12 in Roland Morris Disability Questionnaire |
0.09; 1.00 | — |
| SECONDARY Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug |
-0.30; -0.48 | — |
| SECONDARY Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug |
-0.27; -0.37 | — |
| SECONDARY Use of Rescue Medication |
0.87; 0.82; 0.93; 1.03; 0.93; 1.02 | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained at Screening, prior to any procedure being performed
Exclusion Criteria
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
- Diagnosis of moderate to severe hepatic impairment.
- History of severe emesis with opioids
- Clinically significant sleep apnea
Data sourced from ClinicalTrials.gov (NCT01256450). 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.