Conditions: Low Back Pain
Keywords: CLBP Chronic Low Back Pain Chronic Pain Back Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 752
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Twice Daily Dosing arm 2: Twice Daily Dosing

Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily intervention 2: Matching Placebo Buccal Film twice daily

Protocol document: