Clinical Trial

High Dose Oral Omeprazole in High Risk UGIB

Recruiting
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Summary
Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-05-14; most recent amendment 2025-09-12.
Status change: Not Yet Recruiting → Recruiting 2021-02-16
Trial Details
NCT Number NCT04394663
Lead Sponsor King Chulalongkorn Memorial Hospital
Conditions GI Bleeding
Enrollment 128 participants
Start Date 2020-10-01
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-18