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NCT03551691 · ClinicalTrials.gov registry record · Phase 2

Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

A Phase 2 study, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT03551691: Completed Phase 2 study, sponsored by Children's Hospital of Philadelphia.

NCT03551691 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03551691, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. Markers of fat absorption will be measured after each treatment course.

Primary Outcome

Gold standard measurement of fat malabsorption

Interventions

  • DRUG Placebo oral capsule
  • DRUG Omeprazole 20mg Capsule

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2018-08-07
Est. Completion 2022-11-02
Phase Phase 2
Children's Hospital of Philadelphia

431 total trials

What the finished NCT03551691 record still lists

NCT03551691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT03551691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03551691 about?

NCT03551691 is a clinical study titled "Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)". This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over ...

What is the current status of trial NCT03551691?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2018-08-07. Estimated completion is 2022-11-02.

What interventions are being tested in trial NCT03551691?

The interventions under investigation include: Placebo oral capsule (DRUG), Omeprazole 20mg Capsule (DRUG).

Who is sponsoring clinical trial NCT03551691?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03551691's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03551691, the US trial registry maintained by the National Library of Medicine. NCT03551691 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.