Tegoprazan-containing Sequential for H. Pylori

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-12

Brief Summary

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As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

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Detailed Description

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Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)

esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.

Group Type ACTIVE_COMPARATOR

Esomeprazole-containing sequential H. pylori eradication therapy

Intervention Type DRUG

Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)

Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)

tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.

Group Type EXPERIMENTAL

Tegoprazan-containing sequential H. pylori eradication therapy

Intervention Type DRUG

tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy

Interventions

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Tegoprazan-containing sequential H. pylori eradication therapy

tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy

Intervention Type DRUG

Esomeprazole-containing sequential H. pylori eradication therapy

Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)