Triple Therapy With Tegoprazan in H. Pylori Positive Patients

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-01-29

Brief Summary

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This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

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Detailed Description

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A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan 50 mg

Tegoprazan 50 mg Triple Therapy

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral

Tegoprazan 100 mg

Tegoprazan 100 mg Triple Therapy

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral

RAPAE01

RAPAE01 Triple Therapy

Group Type ACTIVE_COMPARATOR

RAPAE01

Intervention Type DRUG

RAPAE01/Clarithromycin/Amoxicillin BID peroral

Interventions

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Tegoprazan

Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral

Intervention Type DRUG

RAPAE01

RAPAE01/Clarithromycin/Amoxicillin BID peroral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* H. pylori positive at screening
* Subjects who have upper gastrointestinal disease

Exclusion Criteria

* Having received prior therapy for eradication of H. pylori
* Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No