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

2014-07-24 14:05:53 | BioPortfolio

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.

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Pain

Intervention

Hydrocodone bitartrate

Location

HOPE Research Institute, LLC
Phoenix
Arizona
United States
85050

Status

Recruiting

Source

Zogenix, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:05:53-0400

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Medical and Biotech [MESH] Definitions

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