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

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.

Study Overview

• Status: Recruiting
• Conditions: GI Bleeding
• Intervention / Treatment: Drug: High-dose oral omeprazole; Drug: Standard IV PPI

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rapat Pittayanon, MD; Phone Number: 66804224999; Email: rapat125@gmail.com

Study Locations

• Thailand
  • Surin, Thailand, 32000
    • Recruiting
    • Surin hospital
    • Contact: Nutbordee Nalinthassanai, MD; Phone Number: 6644511757; Email: nutbordee@gmail.com
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • King Chulalongkorn Memorial Hospital
      • Contact: Rapat Pittayanon; Email: rapat125@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
• Age > 18 years old

Exclusion Criteria:

• Deny to participate
• Pregnancy or lactation
• Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
• Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
• Bleeding tendency
• Terminal stage of cancer
• ESRD on hemodialysis
• Decompensated liver cirrhosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose oral PPI; Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours	Drug: High-dose oral omeprazole; Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
Active Comparator: Standard IV PPI; Pantoprazole 8 mg/hour IV continuous drip for 72 hours	Drug: Standard IV PPI; Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of 3-day peptic ulcer rebleeding	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of 24-hour gastric pH above 6	3 days
Rate of 30-day peptic ulcer rebleeding	30 days

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: oral proton pump inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole
• Other Study ID Numbers: RP019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No