High Dose Oral Omeprazole in High Risk UGIB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-dose oral omeprazole, Standard IV PPI.
- Who it may be relevant to
- Registry conditions: GI Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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
Primary outcome measures
- Rate of 3-day peptic ulcer rebleeding [Time frame: 3 days]
Secondary outcome measures (2)
- Percentage of 24-hour gastric pH above 6 [Time frame: 3 days]
- Rate of 30-day peptic ulcer rebleeding [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Thailand · 2 centers
- King Chulalongkorn Memorial Hospital — Pathum Wan
- Surin Hospital — Surin
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. PMID 42438169
Identifiers
NCT: NCT04394663 · RP019