CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 49 enrolled
Drug / intervention
Ultrase® MT12drug
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/NCT00880100
NCT00880100Phase 3Completed
CompareCT.gov

Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years Old

Forest Laboratories·interventional·Posted Apr 13, 2009·Updated Mar 16, 2017

In Brief

A Phase 3 clinical trial evaluating Ultrase® MT12 for Cystic Fibrosis and Pancreatic Insufficiency. Completed, enrolled 49 participants across 15 sites.

Detailed Summary

Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.2 years ago

Interventions

Ultrase® MT12drug

Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.