Status:
WITHDRAWN
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
Lead Sponsor:
BioDelivery Sciences International
Conditions:
Pain
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA B...
Eligibility Criteria
Inclusion
- 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 \[11 point NRS\] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01431742
Start Date
July 1 2012
End Date
July 1 2013
Last Update
April 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Marietta, Georgia, United States