NCT01115569

Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone Bitartrate	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

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-05-04
• Last updated: 2022-11-09
• Results posted: 2014-04-25

Locations

50 sites across 1 country: United States