Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217204
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
An Effectiveness Safety and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
A Phase II Randomized Investigator-Blinded Parallel-Group Pilot Study Evaluating the Safety Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption
Status:
COMPLETED
Status Verified Date:
2010-04
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 evaluate the effectiveness and safety of PANCREASE MT pancrelipase microtablets to improve steatorrhea excessive excretion of fat in feces in infants and toddlers with cystic fibrosis who have pancreatic insufficiency and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers
Detailed Description:
The objective of this randomized Investigator-blinded parallel group multicenter pilot study is to evaluate the preliminary safety palatability and effectiveness of pancrelipase microtablets to improve fat absorption The hypothesis is that PANCREASE MT will provide effective safe and palatable pancreatic enzyme supplementation to be used for the treatment of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic insufficiency On Day 1 of the study parents will be instructed to administer 500 units lipasekgmeal for a full five days Stool will be collected and analyzed during the last 72 hours of this baseline period On Day 6 of the study subjects will be randomly assigned to one of four treatment groups Parents will be instructed to administer the appropriate dose for a full five days and stool will be collected and analyzed during the last 72 hours of this randomized treatment period Patients will receive PANCREASE MT 500 units lipasekgmeal by mouth for a maximum of five doses per day for the first 120 hours Patients will receive PANCREASE MT 500 1000 1500 or 2000 units lipasekgmeal by mouth for a maximum of five meals per day for the next 120 hours
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