Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Triple Therapy With Tegoprazan, Amoxicillin and Clarithromycin in H. Pylori Positive Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04128917

Enrollment

102

Registered

2019-10-16

Start date

2020-01-21

Completion date

2021-01-29

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

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.

Detailed description

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.

Interventions

DRUGTegoprazan

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

DRUGRAPAE01

RAPAE01/Clarithromycin/Amoxicillin BID peroral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
H. pylori eradication rate	Day 49	Assess H. pylori eradication rate by UBT

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026