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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Delayed release capsules
Delayed release capsules
University of Southern California /ID# 164571
Los Angeles, California, United States
Landon Pediatric Foundation /ID# 215411
Ventura, California, United States
Nemours Children's Health System /ID# 164553
Jacksonville, Florida, United States
Central FL Pulmonary Orlando /ID# 164558
Orlando, Florida, United States
The Cystic Fibrosis Institute /ID# 210757
Northfield, Illinois, United States
University of Iowa Hospitals and Clinics /ID# 164551
Iowa City, Iowa, United States
Via Christi Research /ID# 214266
Wichita, Kansas, United States
UH Cleveland Medical Center /ID# 206095
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 212853
Cleveland, Ohio, United States
Nationwide Children's Hospital /ID# 225628
Columbus, Ohio, United States
...and 3 more locations
Part 1 Coefficient of Fat Absorption (CFA)
CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Time frame: Up to Day 8 of each DB treatment period
Part 2 Coefficient of Fat Absorption (CFA)
CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Time frame: Up to Day 8 of each DB treatment period
Coefficient of Nitrogen Absorption (CNA)
The CNA is calculated as 100\*\[nitrogen intake - nitrogen excretion\]/nitrogen intake. Nitrogen intake was determined from protein content of food consumed on Day 3, 4, 5 of each treatment period. Nitrogen excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Time frame: Up to Day 8 of each DB treatment period
Stool Fat
Total amount of fat excreted during the stool collection period. Stool fat was determined from the stool fat in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Time frame: Up to Day 8 of each DB treatment period
Stool Weight
Stool weight was determined from the net weight of the stool samples collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.
Time frame: Up to Day 8 of each DB treatment period
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