drugset / Trial / NCT01256450

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

NCT01256450 ↗

Phase 3 Completed 334 enrolled BioDelivery Sciences International
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2010-11
Primary completion
2011-07
Completion
2011-07

Outcome

Missed primary endpoint

registry p = .5870; Mean Difference (Net) -0.14 (95% CI -0.646 to 0.366); ANCOVA NCT01256450 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified — Oral

Indications

No indication recorded.