A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Study Identifier
M16-111
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 4
Sex
Female & Male
Age
12+ years
Protocol Summary
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), as measured by coefficient of fat absorption (CFA). Part 2 is a study to demonstrate that Creon (pancrelipase) manufactured with an alternate active pharmaceutical ingredient site (AAPIS) is non-inferior to currently marketed active control (Creon®) in participants with EPI due to CF, as measured by CFA. Safety is evaluated in each part.
Study Locations
Location
Status
Location
University of Southern California /ID# 164571
Los Angeles, California, United States, 90033
Status
Not applicable
Location
Landon Pediatric Foundation /ID# 215411
Ventura, California, United States, 93003-3099
Status
Not applicable
Location
Nemours Children's Health System /ID# 164553
Jacksonville, Florida, United States, 32207
Status
Not applicable
Location
Central FL Pulmonary Orlando /ID# 164558
Orlando, Florida, United States, 32803
Status
Not applicable
Location
The Cystic Fibrosis Institute /ID# 210757
Northfield, Illinois, United States, 60093
Status
Not applicable
Location
University of Iowa Hospitals and Clinics /ID# 164551
Iowa City, Iowa, United States, 52242
Status
Not applicable
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