NCT04394663 High Dose Oral Omeprazole in High Risk UGIB
| NCT ID | NCT04394663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King Chulalongkorn Memorial Hospital |
| Condition | GI Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2020-10-01 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Rapat Pittayanon, MD
PRINCIPAL INVESTIGATOR
King Chulalongkorn Memorial Hospital
Frequently Asked Questions
Who can join the NCT04394663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying GI Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04394663 currently recruiting?
Yes, NCT04394663 is actively recruiting participants. Contact the research team at rapat125@gmail.com for enrollment information.
Where is the NCT04394663 trial being conducted?
This trial is being conducted at Pathum Wan, Thailand, Surin, Thailand.
Who is sponsoring the NCT04394663 clinical trial?
NCT04394663 is sponsored by King Chulalongkorn Memorial Hospital. The principal investigator is Rapat Pittayanon, MD at King Chulalongkorn Memorial Hospital. The trial plans to enroll 128 participants.