High Dose Oral Omeprazole in High Risk UGIB

Not Applicable

Recruiting

• Conditions: GI Bleeding
• Interventions: Drug: Standard IV PPI; Drug: High-dose oral omeprazole

• Registration Number: NCT04394663
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-10-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard IV PPI	Standard IV PPI	Pantoprazole 8 mg/hour IV continuous drip for 72 hours
High-dose oral PPI	High-dose oral omeprazole	Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours

Primary Outcome Measures

Name	Time	Method
Percentage of 24-hour gastric pH above 6	3 days

Secondary Outcome Measures

Name	Time	Method
Rate of 30-day peptic ulcer rebleeding	30 days
Rate of 3-day peptic ulcer rebleeding	3 days

Trial Locations

Locations (1)

Rapat Pittayanon; 🇹🇭 Pathum Wan, Bangkok, Thailand