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Proton Pump Inhibitor
Treatment Arm for Pancreatic Insufficiency
Phase 2
Waitlist Available
Led By Virginia A Stallings, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cystic fibrosis and pancreatic insufficiency (Fecal elastase <200 ug/g stool)
Age ≥12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 28 days of treatment or placebo
Awards & highlights
Study Summary
This trial is investigating whether omeprazole can help improve fat absorption in people with cystic fibrosis and pancreatic insufficiency.
Eligible Conditions
- Pancreatic Insufficiency
- Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 28 days of treatment or placebo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 28 days of treatment or placebo
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coefficient of fat absorption
Secondary outcome measures
Duodenal pH
Fat absorption via Malabsorption Blood Test
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment ArmActive Control1 Intervention
Subjects will take omeprazole 40mg daily for 28 days, then undergo assessments of fat absorption.
Group II: Placebo ArmPlacebo Group1 Intervention
Subjects will take a placebo daily for 28 days, then undergo assessments of fat absorption.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
706 Previous Clinical Trials
8,571,421 Total Patients Enrolled
4 Trials studying Pancreatic Insufficiency
110 Patients Enrolled for Pancreatic Insufficiency
Chiesi USA, Inc.Industry Sponsor
8 Previous Clinical Trials
6,085 Total Patients Enrolled
Virginia A Stallings, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
58 Total Patients Enrolled
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