High Dose Oral Omeprazole in High Risk UGIB

Recruiting now · Not applicable

Conditions studied: GI Bleeding

In brief

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.

Key facts

Study ID

NCT04394663

Run by

King Chulalongkorn Memorial Hospital

People needed

128

Starts

2020-10-01

Expected to finish

2025-12-31

Last updated by the study team

2025-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• King Chulalongkorn Memorial Hospital — Pathum Wan, Bangkok, Thailand (enrolling)
• Surin Hospital — Surin, Thailand (enrolling)

Full record on ClinicalTrials.gov

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