Phase 3
Completed N=302
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Source: ClinicalTrials.gov NCT01298765 ↗Enrolled (actual)
302
Serious AEs
1.3%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in NRS Pain Intensity — -0.24 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in NRS Pain Intensity |
-0.24 | — |
| SECONDARY Patient Global Impression of Change in Pain Intensity |
5.5 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication/Global Satisfaction |
76.6 | — |
| SECONDARY Subjects Overall Satisfaction With Study Drug |
4.1 | — |
| SECONDARY Investigator's Overall Satisfaction With Study Drug |
4.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic pain:
- Subjects completing study BUP-301 (low back pain) or
- Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and 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 prior to any procedure being performed
Exclusion Criteria
- Cancer related pain
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
- History of severe emesis with opioids
- Clinically significant sleep apnea in the judgment of the investigator
Data sourced from ClinicalTrials.gov (NCT01298765). 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.