Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

HK inno.N Corporation102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

102

Conditions

Helicobacter Pylori Infection

Interventions

TegoprazanDRUG

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

RAPAE01DRUG

RAPAE01/Clarithromycin/Amoxicillin BID peroral

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Chung-Ang University Hosptial

Seoul, South Korea

Outcomes

Primary Outcomes

H. pylori eradication rate

Assess H. pylori eradication rate by UBT

Time frame: Day 49

Data from ClinicalTrials.gov

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