CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Omeprazole 20mg Capsule +1 moredrug
Likely dose
Omeprazole 20mg Capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03551691
NCT03551691Phase 2Completed

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

Children's Hospital of Philadelphia·interventional·Posted Jun 11, 2018·Updated Apr 30, 2024

In Brief

A Phase 2 clinical trial evaluating Omeprazole 20mg Capsule and Placebo oral capsule for Pancreatic Insufficiency and Cystic Fibrosis. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsChiesi USA, Inc.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 11, 2018
Enrollment StartAug 7, 2018
Primary CompletionNov 2, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.1 years ago

Interventions

Omeprazole 20mg Capsuledrug

Omeprazole 20mg daily for 28 days

Placebo oral capsuledrug

Identically-appearing capsule to omeprazole for 28 days