Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain

Withdrawn before enrolling · Phase 3

Conditions studied: Pain, Low Back Pain

In brief

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 Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

Key facts

Study ID

NCT01431742

Run by

BioDelivery Sciences International

People needed

0

Starts

2012-07-01

Expected to finish

2013-07-01

Last updated by the study team

2012-04-17

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 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

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 — Marietta, Georgia, United States

Full record on ClinicalTrials.gov

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