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drugset / Trial / NCT01115569

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

NCT01115569 ↗

Phase 3 Completed 424 enrolled Zogenix, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-05
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject hydrocodone bitartrate Unknown 10 mg Oral
Subject hydrocodone bitartrate Unknown 20 mg Oral
Subject hydrocodone bitartrate Unknown 30 mg Oral
Subject hydrocodone bitartrate Unknown 40 mg Oral
Subject hydrocodone bitartrate Unknown 50 mg Oral

Indications

chronic pain syndrome