Efficacy & Safety of Ultrase® MT20 in Improving the Coefficient of Fat

Status Completed

Clinical Trial 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.

Clinical Trial Description

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%. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pancreatic Insufficiency

Clinical Trial Details

NCT number	NCT00513682
Study type	Interventional
Source	Forest Laboratories
Contact
Status	Completed
Phase	Phase 3
Start date	July 2007
Completion date	April 2008

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms