Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

Completed · Phase 3

Conditions studied: Pain, Low Back Pain, Osteoarthritis, Neuropathic Pain

In brief

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Key facts

Study ID

NCT01298765

Run by

BioDelivery Sciences International

People needed

302

Starts

2011-03-01

Expected to finish

2012-08-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Arcadia, California, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Westminster, Colorado, United States
• Study site — DeLand, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Bloomington, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Leawood, Kansas, United States
• Study site — Watertown, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Altoona, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — El Paso, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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