drugset / Trial / NCT00465647

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

NCT00465647

Phase 4 Completed 116 enrolled Purdue Pharma LP
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.

Timeline

Start
2007-04
Primary completion
2009-05
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified Intravenous

Indications

No indication recorded.