Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04394663

High Dose Oral Omeprazole in High Risk UGIB

Led by King Chulalongkorn Memorial Hospital · Updated on 2025-09-18

128

Participants Needed

2

Research Sites

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

High Dose Oral Omeprazole in High Risk UGIB

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with peptic ulcer bleeding showing Forrest classification Ia (spurting hemorrhage), IIa (oozing hemorrhage), or Ib (non-bleeding visible vessel) on endoscopy
  • Age over 18 years old
Not Eligible

You will not qualify if you...

  • Decline to participate
  • Pregnancy or breastfeeding
  • Low risk peptic ulcer bleeding such as clean base ulcer or flat pigmented spot
  • Non-peptic ulcer bleeding causes like erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (e.g., Dieulafoy), or malignant ulcer
  • Bleeding disorders
  • Terminal stage cancer
  • End-stage renal disease on hemodialysis
  • Decompensated liver cirrhosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand, 10330

Actively Recruiting

2

Surin Hospital

Surin, Thailand, 32000

Actively Recruiting

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Research Team

R

Rapat Pittayanon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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