Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408317
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-12-04
Brief Title:
Safety and Efficacy Study of ULTRASE MT20 in Participants With Cystic Fibrosis CF and Exocrine Pancreatic Insufficiency PI
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Crossover Study to Compare the Safety and Efficacy of Ultrase MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis CF
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:
The purpose of this study is to assess the safety and efficacy of Ultrase MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis CF and exocrine pancreatic insufficiency EPI This study is sponsored by Aptalis Pharma formerly Axcan
Detailed Description:
This is a Phase III multicenter randomized double-blind two-period cross-over placebo-controlled study designed to compare the efficacy and safety of Ultrase MT20 to placebo in participants with CF and pancreatic insufficiency The study consists of a screening period up to 11 days and two treatment periods 6-7 days During screening period participants will be treated with open-label Ultrase MT18 or MT20 Each treatment period will be preceded by a stabilization period 4 days and the two treatment periods are separated by a break period 3-6 days A safety follow-up visit will be performed 7-10 days after discharge from the last treatment period
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