Who is sponsoring NCT01256450?

NCT01256450 is sponsored by BioDelivery Sciences International.

What condition does NCT01256450 study?

NCT01256450 studies Pain, Low Back Pain.

What drugs are being tested in NCT01256450?

Interventions: Buprenorphine, Placebo.

What is the status of NCT01256450?

NCT01256450 is currently COMPLETED.

Last reviewed 2017-01-12 · How we verify

A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain

NCT01256450 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

Details

Lead sponsor	BioDelivery Sciences International
Phase	Phase 3
Status	COMPLETED
Enrolment	334
Start date	2010-11
Completion	2011-07

Conditions

Pain
Low Back Pain

Interventions

Buprenorphine
Placebo

Primary outcomes

Change in Pain Intensity From Baseline to Week 12 — Baseline, Week 12
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Countries

United States