Overview

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BioDelivery Sciences International
Endo Pharmaceuticals
Treatments:
Buprenorphine
Criteria
Inclusion Criteria:

- Male or non-pregnant and non-nursing female aged 18 or older

- History of moderate to severe chronic pain:

1. Subjects completing study BUP-301 (low back pain) or

2. 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