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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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2017

At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Pharmaceutical Industries
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 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.
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