Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513682
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2007-08-07
Brief 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
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 investigators 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
Screening phase this phase will last 15 days and all participants will take Ultrase MT20 as per investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None