Who is sponsoring NCT01431742?

NCT01431742 is sponsored by BioDelivery Sciences International.

What condition does NCT01431742 study?

NCT01431742 studies Pain, Low Back Pain.

What drugs are being tested in NCT01431742?

Interventions: BEMA Buprenorphine.

What is the status of NCT01431742?

NCT01431742 is currently WITHDRAWN.

Last reviewed 2012-04-16 · How we verify

An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain

NCT01431742 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	BioDelivery Sciences International
Phase	Phase 3
Status	WITHDRAWN
Start date	2012-07
Completion	2013-07

Conditions

Pain
Low Back Pain

Interventions

BEMA Buprenorphine

Primary outcomes

Mean change in pain intensity — Baseline up to approximately Week 52
The average of the visit pain scores for Baseline up to approximately Week 52

Countries

United States