NCT04394663

High Dose Oral Omeprazole in High Risk UGIB

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GI Bleeding

Interventions

Type	Name	Description
DRUG	High-dose oral omeprazole	Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
DRUG	Standard IV PPI	Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-05-30
• Completion: 2025-12-31
• First posted: 2020-05-19
• Last updated: 2025-09-18

Locations

2 sites across 1 country: Thailand