High-dose oral omeprazole for treating peptic ulcer bleeding
Official title: High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial
Run by King Chulalongkorn Memorial Hospital · NCT04394663 · Data updated 2026-11-12
This study tests if taking high-dose oral omeprazole can help prevent re-bleeding in patients with peptic ulcers just like the more expensive intravenous treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 2 sites (Pathum Wan, Bangkok and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | May 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT04394663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with high-risk peptic ulcer bleeding as identified by specific endoscopic findings.
✕Probably not a fit
Patients with low-risk peptic ulcer bleeding or other types of gastrointestinal bleeding unrelated to peptic ulcers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of high-dose oral omeprazole compared to standard intravenous proton pump inhibitors (PPIs) in preventing re-bleeding in patients with peptic ulcer bleeding after successful endoscopic treatment. It aims to determine if the oral formulation can provide similar outcomes to the more expensive intravenous option. The study focuses on patients with specific types of peptic ulcers classified as high risk for re-bleeding. By using a locally made PPI, the study also seeks to assess cost-effectiveness in treatment.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and cost-effective treatment option for patients with peptic ulcer bleeding.
How similar studies have gone: Previous studies have shown the efficacy of high-dose oral PPIs, but this study aims to confirm non-inferiority with a locally made option, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel) * Age \> 18 years old Exclusion Criteria: * Deny to participate * Pregnancy or lactation * Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot * Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer * Bleeding tendency * Terminal stage of cancer * ESRD on hemodialysis * Decompensated liver cirrhosis
Where it's running
-
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand Recruiting -
Surin Hospital
Surin, Thailand Recruiting
Study contacts
- Principal investigator: Rapat Pittayanon, MD — King Chulalongkorn Memorial Hospital
- Study coordinator: Rapat Pittayanon, MD
- Email: rapat125@gmail.com
- Phone: 66804224999
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis
This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.
-
Evaluating a new clip for closing gastrointestinal defects
This study is testing a new clip designed to close larger holes in the gastrointestinal tract during endoscopic procedures to see how well it works for patients with GI issues.
-
Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia
This study tests whether a low-FODMAP diet helps adults with functional dyspepsia compared with standard dietary advice.
-
Carbon footprint of diagnostic versus therapeutic upper GI endoscopy
This project will measure how much carbon is produced by diagnostic endoscopy for dyspepsia compared with therapeutic endoscopy for non-variceal upper GI bleeding.
-
Comparing two methods to guide iron treatment in dialysis patients with anemia
This study is testing whether using a new method to guide iron treatment can help adults with kidney disease and anemia feel better compared to the standard method.
-
Investigating the causes and progression of neurocognitive disorders in Thailand
This study is trying to understand how neurocognitive disorders like dementia progress in people in Thailand by looking at blood samples and cognitive tests from both healthy individuals and those with memory issues.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.