Conditions: Chronic Low Back Pain
Keywords: Pain Opioid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 905
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Detailed description:

Arms:
arm 1: Hydrocodone bitartrate (HYD) once daily (q24h) tablets arm 2: Placebo to match hydrocodone bitartrate once daily tablets

Interventions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets intervention 2: Placebo to match hydrocodone bitartrate q24h tablets
Intervention descriptions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily intervention 2: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Protocol document: