NCT04930991

High Dose Omeprazole in Patients With Pancreatic Cancer

A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.

Detailed description

During this study patients will receive treatment of omeprazole at the dose depending on group enrollment * Group A will receive omeprazole 80 mg, twice a day for 12-14 days unless unacceptable toxicity * Group B, will receive omeprazole 20 mg, once a day for 12-14 days Patients will receive treatment for 2\~3 weeks during the study, and 2 months of follow up. Total accrual is anticipated to take 2 years.

Conditions

• Exocrine Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Omeprazole	Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.

Timeline

• Start date: 2021-09-07
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2021-06-18
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study