CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
Ultrase® MT20drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00513682
NCT00513682Phase 3Completed
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Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)

Forest Laboratories·interventional·Posted Aug 9, 2007·Updated Mar 16, 2017

In Brief

A Phase 3 clinical trial evaluating Ultrase® MT20 for Cystic Fibrosis and Pancreatic Insufficiency. Completed, enrolled 9 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pancreatic Insufficiency
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.9 years ago

Interventions

Ultrase® MT20drug

Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be followed by a washout phase of 6 to 7 days, in which participants will receive only high-fat diet; then stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) will be administered orally for 7 to 11 days during treatment phase. The stabilized dose should not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).