High Dose Oral Omeprazole in High Risk UGIB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-12-31

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 in term of rebleeding, as well as 24-hour gastric pH monitoring.

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Detailed Description

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Conditions

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GI Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will not know the assigned treatment.

Study Groups

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High-dose oral PPI

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

Group Type EXPERIMENTAL

High-dose oral omeprazole

Intervention Type DRUG

Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.

Standard IV PPI

Pantoprazole 8 mg/hour IV continuous drip for 72 hours

Group Type ACTIVE_COMPARATOR

Standard IV PPI

Intervention Type DRUG

Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Interventions

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High-dose oral omeprazole

Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.

Intervention Type DRUG

Standard IV PPI

Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No