Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
Public ClinicalTrials.gov record NCT05069597. 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 Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug. Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States. Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days. Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05069597
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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 14, 2021 (Actual)
- Primary completion
- Jul 7, 2023 (Actual)
- Completion
- Aug 28, 2023 (Actual)
- Last update posted
- Jul 23, 2024
2021 – 2023
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research /ID# 231076 | Mobile | Alabama | 36608-1771 | — |
| Valley Children's Hospital /ID# 231452 | Madera | California | 93636 | — |
| University of Florida - Archer /ID# 233411 | Gainesville | Florida | 32610 | — |
| Atlantic Medical Research /ID# 239568 | Margate | Florida | 33063-5737 | — |
| University of Miami, Miller School of Medicine /ID# 239415 | Miami | Florida | 33136 | — |
| GI Pros /ID# 239486 | Naples | Florida | 34102-5449 | — |
| Central FL Pulmonary Orlando /ID# 245863 | Orlando | Florida | 32803 | — |
| Asr, Llc /Id# 239566 | Nampa | Idaho | 83687 | — |
| UMass Chan Medical School /ID# 230476 | Worcester | Massachusetts | 01655 | — |
| The Curators of the University of Missouri /ID# 233331 | Columbia | Missouri | 65211 | — |
| Dartmouth-Hitchcock Medical Center /ID# 231633 | Lebanon | New Hampshire | 03756 | — |
| Albany Medical College-Pulmonary /ID# 250041 | Albany | New York | 12208-3504 | — |
| NYU Langone Health /ID# 233417 | New York | New York | 10016-2708 | — |
| Wake Forest Baptist Health /ID# 229537 | Winston-Salem | North Carolina | 27157-0001 | — |
| University of Cincinnati /ID# 229511 | Cincinnati | Ohio | 45267-0585 | — |
| UH Cleveland Medical Center /ID# 246065 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Main Campus /ID# 245864 | Cleveland | Ohio | 44195 | — |
| Options Health Research, LLC /ID# 239535 | Tulsa | Oklahoma | 74104 | — |
| Baylor College of Medicine Medical Center /ID# 233441 | Houston | Texas | 77030-4202 | — |
| Univ Texas HSC San Antonio /ID# 239060 | San Antonio | Texas | 78229-3901 | — |
| West Virginia University Hospitals /ID# 239593 | Morgantown | West Virginia | 26506 | — |
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 NCT05069597, 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 Jul 23, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05069597 live on ClinicalTrials.gov.