High Dose Oral Omeprazole in High Risk UGIB

NCT04394663 | Recruiting

• 1 other identifier: RP019
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

oral proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Rate of 3-day peptic ulcer rebleeding

  3 days

Secondary Outcomes (2)

• Percentage of 24-hour gastric pH above 6

  3 days

• Rate of 30-day peptic ulcer rebleeding

  30 days

Study Arms (2)

High-dose oral PPI

EXPERIMENTAL

Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours

Drug: High-dose oral omeprazole

Standard IV PPI

ACTIVE COMPARATOR

Pantoprazole 8 mg/hour IV continuous drip for 72 hours

Drug: Standard IV PPI

Interventions

High-dose oral omeprazole DRUG

Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.

High-dose oral PPI

Standard IV PPI DRUG

Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Standard IV PPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (2)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

Surin Hospital

Surin, 32000, Thailand

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rapat Pittayanon, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rapat Pittayanon, MD

CONTACT

66804224999; rapat125@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not know the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Gastrointestinal Unit

Model Details: The patients with successful endoscopic hemostasis in peptic ulcer bleeding were equally randomized to either high-dose oral PPI or standard IV PPI for 3 days

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: October 1, 2020
• Primary Completion: May 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

TH (2)