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
  • Cystic Fibrosis
  • Study Drug
  • Pancrelipase
  • 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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