Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

Summary

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Timeline

Start

2012-08

Primary completion

2013-12

Completion

2013-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); DB Buprenorphine HCl Buccal Film vs DB Placebo Film; p = 0.0012; Median Difference (Net) -0.67 (95% CI -1.07 to -0.26); ANCOVA NCT01633944 ↗

Drugs

Indications

No indication recorded.