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
Public ClinicalTrials.gov record NCT03924947. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03924947
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 23, 2019 (Actual)
- Primary completion
- Jul 11, 2022 (Actual)
- Completion
- Jul 11, 2022 (Actual)
- Last update posted
- Sep 28, 2023
2019 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California /ID# 164571 | Los Angeles | California | 90033 | — |
| Landon Pediatric Foundation /ID# 215411 | Ventura | California | 93003-3099 | — |
| Nemours Children's Health System /ID# 164553 | Jacksonville | Florida | 32207 | — |
| Central FL Pulmonary Orlando /ID# 164558 | Orlando | Florida | 32803 | — |
| The Cystic Fibrosis Institute /ID# 210757 | Northfield | Illinois | 60093 | — |
| University of Iowa Hospitals and Clinics /ID# 164551 | Iowa City | Iowa | 52242 | — |
| Via Christi Research /ID# 214266 | Wichita | Kansas | 67214-2878 | — |
| UH Cleveland Medical Center /ID# 206095 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Main Campus /ID# 212853 | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital /ID# 225628 | Columbus | Ohio | 43205-2664 | — |
| Children's Hospital of Philadelphia - Main /ID# 208114 | Philadelphia | Pennsylvania | 19104-4319 | — |
| Vanderbilt University Medical Center /ID# 213434 | Nashville | Tennessee | 37232-0011 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 164574 | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03924947, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03924947 live on ClinicalTrials.gov.