Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Phase 1 Completed 52 enrolled Shire

RandomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Timeline

Start: 2010-10-08
Primary completion: 2013-06-27
Completion: 2013-06-27

Publications

Cuffari C, Pierce D, Korczowski B, Fyderek K, Van Heusen H, Hossack S, Wan H, Edwards AY, Martin P. Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis. Drug Des Devel Ther. 2016 Feb 4;10:593-607. doi: 10.2147/DDDT.S95316. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	30 mg/kg	Oral
Subject	Mesalamine	Small molecule	60 mg/kg	Oral
Subject	Mesalamine	Small molecule	100 mg/kg	Oral

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Summary

Timeline

Publications

Drugs

Indications