A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain.
Phase of Trial: Phase III
Latest Information Update: 01 Dec 2015
At a glance
- Drugs Hydrocodone (Primary)
- Indications Back pain
- Focus Registrational; Therapeutic Use
- Sponsors Zogenix
- 13 Feb 2014 Results have been published in Pain Medicine according to a Zogenix media release. Results were also summarised in the media release.
- 21 May 2013 An NDA submitted in March 2013 is anticipated to be reviewed by the FDA in the second half of 2013, according to the Q1 2013 financial report released by Zogenix.
- 07 Dec 2012 Results from this trial were included in a NDA submitted to the US FDA.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History