CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
Hydrocodone ERdrug
Likely dose
Hydrocodone ER 90 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/NCT01223365
NCT01223365Phase 3Completed
CompareCT.gov

A 12-Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Require Opioid Treatment for an Extended Period of Time

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 19, 2010·Updated Jun 5, 2017

In Brief

A Phase 3 clinical trial evaluating Hydrocodone ER for Chronic Pain. Completed, enrolled 330 participants across 54 sites.

Detailed Summary

The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2010
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.7 years ago

Interventions

Hydrocodone ERdrug

Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.