Last reviewed · How we verify
NCT03551691
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Phase 2 trial testing Omeprazole 20mg Capsule in Pancreatic Insufficiency in 19 participants. Completed in 2 November 2022.
2 November 2022
Quick facts
| Lead sponsor | Children's Hospital of Philadelphia |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 7 August 2018 |
| Primary completion | 2 November 2022 |
| Estimated completion | 2 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Omeprazole 20mg Capsule
- Placebo oral capsule
Conditions studied
- Pancreatic Insufficiency — all drugs for Pancreatic Insufficiency →
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Children's Hospital of Philadelphia
Who can join
12 and older, any sex, with Pancreatic Insufficiency or Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Drug therapies for reducing gastric acidity in people with cystic fibrosis.
Ng SM, Moore HS. · · 2021 · cited 3× · PMID 33905540 · DOI 10.1002/14651858.cd003424.pub5
Verify or expand the search:
- PubMed search for NCT03551691
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pancreatic Insufficiency
Currently open trials in the same condition.
- NCT05466838 — PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial · NA · active not recruiting
- NCT04731272 — GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance · Phase 2 · recruiting
Other Children's Hospital of Philadelphia trials
Trials by the same sponsor.
- NCT07023380 — EoE Food Test Pilot Study · NA · not yet recruiting
- NCT06693752 — CEUS Evaluation of Hydrocephalus in Neonates and Infants · Phase 2 · recruiting
- NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
- NCT07444528 — Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants · enrolling by invitation
- NCT07321327 — Implementation Strategies for Caregiver and Teacher Use of Behavioral Interventions: Aim 2 · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03551691 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
- Last refreshed: 30 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03551691.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing