A Phase 2B, Open-label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Effectiveness of Hydrocodone Bitartrate Extended-Release Tablets (HYD) in Children, Aged 12 to 17 Years Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Around-the-Clock Opioid Analgesics

Trial Profile

A Phase 2B, Open-label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Effectiveness of Hydrocodone Bitartrate Extended-Release Tablets (HYD) in Children, Aged 12 to 17 Years Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Around-the-Clock Opioid Analgesics

Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2017

At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Pain
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Purdue Pharma
  • Most Recent Events

    • 21 Apr 2017 Status changed from not yet recruiting to withdrawn prior to enrolment.
    • 11 Dec 2015 Planned End Date changed from 1 Jul 2018 to 1 Jul 2019, according to ClinicalTrials.gov record.
    • 11 Dec 2015 Planned primary completion date changed from 1 Jul 2018 to 1 Jul 2019, according to ClinicalTrials.gov record.
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