NCT01256450

Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects. Buprenorphine HCl buccal film 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.

Conditions

• Pain
• Low Back Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine	buccal soluble film; applied to the buccal mucosa twice daily
DRUG	Placebo	buccal soluble film; applied to the buccal mucosa twice daily

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-12-08
• Last updated: 2017-02-27
• Results posted: 2015-12-08

Locations

24 sites across 1 country: United States