Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

Phase 3 Completed 40 enrolled Abbott Products

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

Timeline

Start: 2012-06
Primary completion: 2012-12
Completion: 2012-12

Publications

Kashirskaya NY, Kapranov NI, Sander-Struckmeier S, Kovalev V. Safety and efficacy of Creon(R) micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015 Mar;14(2):275-81. doi: 10.1016/j.jcf.2014.07.006. Epub 2014 Jul 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pancrelipase	Protein / enzyme biologic	2500 iu/kg	Oral
Subject	Pancrelipase	Protein / enzyme biologic	4000 unknown	Oral
Subject	Pancrelipase	Protein / enzyme biologic	10000 iu/kg	Oral

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

Summary

Timeline

Publications

Drugs

Indications