Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain

Phase 2 Completed 86 enrolled Grünenthal GmbH Janssen Research & Development, LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose. Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.

Timeline

Start: 2012-11
Primary completion: 2014-02
Completion: 2014-02

Publications

Results Muse D, Tarau E, Lefeber C, Sohns M, Brett M, Goldberg J, Rosenburg R. Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients. J Pain Res. 2019 May 31;12:1777-1790. doi: 10.2147/JPR.S197039. eCollection 2019.

Drugs

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

Indications

No indication recorded.