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

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Pain, PostoperativePostoperative Pain
Interventions
DRUG

Tapentadol (OS) Oral Solution

Tapentadol OS Bodyweight \<20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight \>=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.

Trial Locations (17)

Unknown

Little Rock

Washington D.C.

Meridian

Ann Arbor

The Bronx

Charlotte

Durham

Toledo

Pittsburgh

Salt Lake City

Hamilton

Ottawa

Sherbrooke

F-75 730 Paris Cedex 15

Rennes

Madrid

Valladolid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY