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RecruitingNCT04394663Updated Sep 18, 2025

High Dose Oral Omeprazole in High Risk UGIB

An interventional study of High-dose oral omeprazole and Standard IV PPI in GI Bleeding, sponsored by King Chulalongkorn Memorial Hospital. Recruiting at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by King Chulalongkorn Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

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Conditions studied

  • GI Bleeding

Keywords

  • oral proton pump inhibitor
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In context

Gastrointestinal Hemorrhage

338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.

This study's planned enrollment of 128 is above the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 43 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • 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

  • Active comparator
    Standard IV PPI

    Pantoprazole 8 mg/hour IV continuous drip for 72 hours

    Drug: Standard IV PPI

Interventions

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

  • DrugStandard IV PPI

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

06

What researchers measure

Primary outcomes

  1. Rate of 3-day peptic ulcer rebleeding

    Time frame: 3 days

Secondary outcomes

  1. Percentage of 24-hour gastric pH above 6

    Time frame: 3 days

  2. Rate of 30-day peptic ulcer rebleeding

    Time frame: 30 days

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Sriyudthsak K, Nalinthassanai N, Sriapiraksa B, Rattanachaisit P, Patcharatrakul T, Pittayanon R. High-Dose Oral Omeprazole Versus Continuous Intravenous Pantoprazole in Patients With High-Risk Peptic Ulcer Bleeding: A Single-Blinded Multicenter RCT. J Gastroenterol Hepatol. 2026 Jul 12. doi: 10.1111/jgh.70566. Online ahead of print. PubMed 42438169 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04394663
Lead sponsor
King Chulalongkorn Memorial Hospital
Responsible party
Rapat Pittayanon (Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
May 19, 2020
Start date
Oct 1, 2020
Primary completion
May 30, 2025
Completion
Dec 31, 2025 (estimated)
Last update
Sep 18, 2025

Study contacts

Rapat Pittayanon, MD
Contact
rapat125@gmail.com
66804224999
Rapat Pittayanon, MD
principal investigator · King Chulalongkorn Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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