Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

Phase 2 Completed 45 enrolled Janssen Research & Development, LLC Grünenthal GmbH · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.

Timeline

Start: 2011-10
Primary completion: 2013-03
Completion: 2013-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapentadol	Small molecule	1 mg/kg	Oral

Indications

No indication recorded.