drugset / Trial / NCT04394663

High Dose Oral Omeprazole in High Risk UGIB

NCT04394663

Recruiting 128 enrolled King Chulalongkorn Memorial Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-10-01
Primary completion
2025-05-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 40 mg Oral
Comparator Pantoprazole Other / unclassified 8 mg Intravenous

Indications

No indication recorded.