CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 922 enrolled
Drug / intervention
Hydrocodone bitartrate q24h film-coated tabletsdrug
Likely dose
Hydrocodone bitartrate q24h film-coated tablets 120 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/NCT01400139
NCT01400139Phase 3Completed
CompareCT.gov

An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain

Purdue Pharma LP·interventional·Posted Jul 22, 2011·Updated Mar 10, 2020

In Brief

A Phase 3 clinical trial evaluating Hydrocodone bitartrate q24h film-coated tablets for Chronic Nonmalignant and Nonneuropathic Pain. Completed, enrolled 922 participants across 98 sites.

Detailed Summary

The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.9 years ago

Interventions

Hydrocodone bitartrate q24h film-coated tabletsdrug

Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily