Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)

Summary

This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.

Timeline

Start

2007-07

Primary completion

2008-03

Completion

2008-04

Outcome

Met primary endpoint

registry Ultrase® MT20 Washout Phase vs Ultrase® MT20 Treatment Phase; p = 0.0013; t-test, 1 sided NCT00513682 ↗

Drugs

Indications