Conditions: Back Pain Lower Back Chronic
Keywords: chronic pain back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

Detailed description:
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call

Arms:
arm 1: Hydrocodone Bitartrate Controlled-Release Capsules arm 2: None

Interventions: intervention 1: Placebo intervention 2: Hydrocodone bitartrate
Intervention descriptions: intervention 1: Capsules, no active substance, shells identical to active comparator capsules intervention 2: dosage form: capsule

Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Protocol document: