A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 30 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
Phase of Trial: Phase III
Latest Information Update: 10 Apr 2017
At a glance
- Drugs Hydrocodone (Primary)
- Indications Back pain
- Focus Registrational; Therapeutic Use
- Sponsors Teva Pharmaceutical Industries
- 25 Feb 2015 According to a Teva Pharmaceutical Industries media release, the US FDA has accepted for review an NDA supported by results of this study, and studies investigating the abuse potential of CEP 33237.
- 30 Oct 2014 According to the Teva Pharmaceutical Industries pipeline, company plans to submit an NDA to the FDA based on results from this study by the end of 2014.
- 08 Oct 2014 Full results will be presented at 15th World Congress on Pain, according to a Teva Pharmaceutical Industries media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History