High Dose Oral Omeprazole in High Risk UGIB

King Chulalongkorn Memorial Hospital

Status: Enrolling

Conditions: GI Bleeding

Treatments: Drug: Standard IV PPI; Drug: High-dose oral omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04394663

RP019

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

High-dose oral PPI

Experimental group

Description:

Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours

Treatment:

Drug: High-dose oral omeprazole

Standard IV PPI

Active Comparator group

Description:

Pantoprazole 8 mg/hour IV continuous drip for 72 hours

Treatment:

Drug: Standard IV PPI