High Dose Oral Omeprazole in High Risk UGIB

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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GI Bleeding

Intervention / Treatment
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* Drug: High-dose oral omeprazole
* Drug: Standard IV PPI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients with successful endoscopic hemostasis in peptic ulcer bleeding were equally randomized to either high-dose oral PPI or standard IV PPI for 3 days
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose oral PPI<br>Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours | Drug: High-dose oral omeprazole<br>* Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.<br>|
| Active Comparator: Standard IV PPI<br>Pantoprazole 8 mg/hour IV continuous drip for 72 hours | Drug: Standard IV PPI<br>* Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of 24-hour gastric pH above 6 |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 3-day peptic ulcer rebleeding |  | 3 days | 
| Rate of 30-day peptic ulcer rebleeding |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral proton pump inhibitor