drugset / Trial / NCT01192295

Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids

NCT01192295

Phase 3 Completed 155 enrolled Purdue Pharma LP
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.

Timeline

Start
2010-11
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxycodone Other / unclassified 10 mg
Subject Oxycodone Other / unclassified 15 mg
Subject Oxycodone Other / unclassified 20 mg
Subject Oxycodone Other / unclassified 30 mg
Subject Oxycodone Other / unclassified 40 mg

Indications

No indication recorded.