Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)

Summary

The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Timeline

Start

2006-11

Primary completion

2007-04

Completion

2007-04

Outcome

Met primary endpoint

registry MEAN Ultrase® MT20: 88.55 (Standard Deviation 4.94) Percent CFA MEAN Placebo: 55.61 (Standard Deviation 25.10) Percent CFA NCT00408317 ↗

registry analysis (superiority or other test); Ultrase® MT20 vs Placebo; p <0.0001; Mean Difference (Net) 34.74; Mixed Models Analysis NCT00408317 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ultrase® MT20	Protein / enzyme biologic	—	Oral

Indications