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NCT05069597 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT05069597 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 30 participants.
The verdict
NCT05069597, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG CREON
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2023-08-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05069597
The ClinicalTrials.gov registry entry for NCT05069597 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CREON is the first listed.
NCT05069597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05069597 about?
NCT05069597 is a clinical study titled "Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon". 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 a...
What is the current status of trial NCT05069597?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2021-10-14. Estimated completion is 2023-08-28.
What interventions are being tested in trial NCT05069597?
The interventions under investigation include: CREON (DRUG).
Who is sponsoring clinical trial NCT05069597?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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