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Proton Pump Inhibitor

High Dose Omeprazole for Pancreatic Cancer (OU202005AJ Trial)

Phase < 1

Recruiting

Led By Ajay Jain, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed exocrine pancreatic cancer with pathology confirmed as adenocarcinoma

Patient is a candidate for surgical resection of pancreatic cancer

Must not have

Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study

Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial is testing if a high dose of a common stomach acid drug is safe for people with a certain kind of cancer.

Who is the study for?

This trial is for adults diagnosed with a specific type of pancreatic cancer known as exocrine adenocarcinoma, who are fit enough for surgery. They must not be pregnant or breastfeeding and should have no major heart issues or conditions that affect medication absorption. A negative pregnancy test is required for women able to bear children.

What is being tested?

The study aims to evaluate the safety and effects of high doses of Omeprazole in patients with exocrine pancreatic cancer. It will involve participants who may or may not have received chemotherapy before joining the trial.

What are the potential side effects?

While the side effects aren't specified here, high doses of Omeprazole could potentially cause digestive disturbances, headaches, dizziness, skin reactions, and an increased risk for bone fractures or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with a specific type of pancreatic cancer.

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I am eligible for surgery to remove pancreatic cancer.

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I can take care of myself and am up and about more than half of the day.

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I am not pregnant and either cannot become pregnant or have had a negative pregnancy test recently.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious heart problems that could affect my safety or the study results.

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My pancreatic tumor is confirmed as a neuroendocrine or another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion

Safety and Tolerability

Secondary study objectives

Correlation

v-ATPase LC3-I and LC3-II expression

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (High Dose)Experimental Treatment1 Intervention

Omeprazole, 80 mg, PO, BID for 2 weeks prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.

Group II: Arm B (Normal Dose)Placebo Group1 Intervention

Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omeprazole

2006

Completed Phase 4

~940

0 / 7Eligibility criteria met