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High Dose Oral Omeprazole in High Risk UGIB

NCT04394663 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-09-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Principal Investigators

  • Rapat Pittayanon, MD · King Chulalongkorn Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394663 on ClinicalTrials.gov