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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries

    • Most Recent Events

    • 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.

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