drugset / Trial / NCT02542098

Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children

NCT02542098

Phase 2 Withdrawn Purdue Pharma LP
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.

Timeline

Start
2017-01
Primary completion
2019-07
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Subject hydrocodone bitartrate Unknown 20 mg Oral
Subject hydrocodone bitartrate Unknown 120 mg Oral

Indications

No indication recorded.