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A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA? Buprenorphine in Subjects With Moderate to Severe Chronic Pain

This study is currently Recruiting

March 2011 By BioDelivery Sciences International

First Recieved on February 16, 2011

Last Updated on March 8, 2011

Sponsor: BioDelivery Sciences International
Collaborators:
Information provided by: BioDelivery Sciences International
Identifier: NCT01298765

Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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-na?ve) 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

Investigators

  • Investigator: Andrew Finn, PharmD - Study Director - BioDelivery Sciences International

Locations

  • Birmingham, Alabama United States

  • Mobile, Alabama United States

  • Phoenix, Arizona United States

  • Arcadia, California United States

  • Fresno, California United States

  • La Jolla, California United States

  • Long Beach, California United States

  • Westminster, Colorado United States

  • Deland, Florida United States

  • Jupiter, Florida United States

  • Plantation, Florida United States

  • Port Orange, Florida United States

  • Marietta, Georgia United States

  • Bloomington, Illinois United States

  • Evansville, Indiana United States

  • Leawood, Kansas United States

  • Watertown, Massachusetts United States

  • Las Vegas, Nevada United States

  • New York, New York United States

  • Raleigh, North Carolina United States

  • Winston-Salem, North Carolina United States

  • Altoona, Pennsylvania United States

  • Austin, Texas United States

  • El Paso, Texas United States

  • Salt Lake City, Utah United States

  • West Jordan, Utah United States

Conditions related to this trial:

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