Conditions: Pain Low Back Pain
Keywords: buccal soluble film enriched enrollment randomized withdrawal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 334
Healthy volunteers: no

Brief 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.

Arms:
arm 1: buprenorphine buccal soluble film arm 2: placebo buccal soluble film

Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: buccal soluble film; applied to the buccal mucosa twice daily intervention 2: buccal soluble film; applied to the buccal mucosa twice daily

Protocol document: