A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain

Phase 1 Completed 37 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old, inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time.

Timeline

Start: 2007-10
Primary completion: 2009-06
Completion: 2009-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tramadol	Other / unclassified	2 mg/kg	Oral

Indications

No indication recorded.