High-dose oral omeprazole for treating peptic ulcer bleeding
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 2 sites (Pathum Wan, Bangkok and 1 other locations) |
| Trial ID | NCT04394663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with high-risk peptic ulcer bleeding as identified by specific endoscopic findings.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pathum Wan, Bangkok and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.