Status:
COMPLETED
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Cystic Fibrosis
Steatorrhea
Eligibility:
All Genders
6-30 years
Phase:
PHASE2
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 w...
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 i...
Eligibility Criteria
Inclusion
- Diagnosis of cystic fibrosis
- Excessive discharge of fat in feces
- Stable patient requiring pancreatic enzyme therapy
Exclusion
- No stable antibiotic therapy for small bowel overgrowth
- No hypersensitivity to pork products
- No use of prokinetics eg, metoclopramide or cisapride within the last 30 days
- No nasogastric feeding tube feeding
- No use of steroids
- No use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00217204
Start Date
July 1 2005
End Date
February 1 2006
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.