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RECRUITING
NCT04394663
NA

High Dose Oral Omeprazole in High Risk UGIB

Sponsor: King Chulalongkorn Memorial Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2020-10-01

Completion Date

2025-12-31

Last Updated

2025-09-18

Healthy Volunteers

No

Conditions

Interventions

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

Locations (2)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Surin Hospital

Surin, Thailand