Overview

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

Status:
Completed

Trial end date:
2006-02-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

Phase:

Phase 2

Details

Lead Sponsor:

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Treatments:

Pancreatin
Pancrelipase