Conditions: Chronic Pain
Keywords: chronic pain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 424
Healthy volunteers: no

Brief summary:
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Detailed description:
Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Arms:
arm 1: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.

Interventions: intervention 1: Hydrocodone Bitartrate
Intervention descriptions: intervention 1: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks

Protocol document: