Cystic Fibrosis Clinical Trial
Official title:
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
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.
This is a Phase III, multicenter, open-label study, which will quantify the improvement of
nutrient absorption when participants are receiving Ultrase® MT20. The improvement will be
demonstrated by comparing the CFA percent (%) and CNA% obtained during a washout of enzyme
with the CFA% and CNA% obtained during a period of treatment with Ultrase® MT20. The study
is also designed to obtain safety data in CF children suffering also from PI taking Ultrase®
MT20. The total duration for the participation of children in this study will be
approximately up to 38 days and will include 3 phases: screening phase, the washout phase
and treatment phase.
Screening phase: this phase will last 15 days and all participants will take Ultrase® MT20
as per investigator's discretion during this period. During the last 4 days, participants
will be stabilized on a high fat diet and with Ultrase® MT20. The individual 'stabilized
dose' of Ultrase® MT20 capsules will be determined for each participant based on the average
number of capsules of Ultrase® MT20 taken during last 4 days.
Washout phase: this phase will last 6 to 7 days. The participants will continue the high-fat
diet but will refrain from taking Ultrase® MT20 or any other enzymes. A 72-hour stool
collection will be performed and all food consumed by the participants will be recorded to
assess the CFA% and CNA%.
Treatment phase: this phase will last 7 to 11 days. The participants will continue the
high-fat diet and will take the 'stabilized dose' of Ultrase® MT20 established during
screening. Another 72-hour stool collection will be performed and all food consumed by the
participants will be recorded to assess the CFA% and CNA%.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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