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Withdrawn prior to enrolment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
- 21 Apr 2017 Status changed from not yet recruiting to withdrawn prior to enrolment.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.