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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
OU202005AJ Trial 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.Check my eligibility
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.See study design
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.
OU202005AJ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
OU202005AJ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion
Safety and Tolerability
Secondary outcome measures
Correlation
pH
v-ATPase LC3-I and LC3-II expression
OU202005AJ 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
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,596 Total Patients Enrolled
Ajay Jain, MDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any other important abnormal lab results that could affect your safety or the study results.My organs are healthy enough for surgery.I have been newly diagnosed with a specific type of pancreatic cancer.I may or may not have had chemotherapy before surgery.I am eligible for surgery to remove pancreatic cancer.I can take care of myself and am up and about more than half of the day.I am not pregnant and either cannot become pregnant or have had a negative pregnancy test recently.I do not have any serious heart problems that could affect my safety or the study results.My pancreatic tumor is confirmed as a neuroendocrine or another type of cancer.You are allergic to any part of the medication or to drugs similar to it called substituted benzimidazoles.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (High Dose)
- Group 2: Arm B (Normal Dose)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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