CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 424 enrolled
Drug / intervention
Hydrocodone Bitartratedrug
Likely dose
Hydrocodone Bitartrate 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01115569
NCT01115569Phase 3Completed
CompareCT.gov

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

Zogenix, Inc.·interventional·Posted May 4, 2010·Updated Nov 9, 2022

In Brief

A Phase 3 clinical trial evaluating Hydrocodone Bitartrate for Chronic Pain. Completed, enrolled 424 participants across 50 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2010
Enrollment StartMay 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.2 years ago

Interventions

Hydrocodone Bitartratedrug

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