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Completed

NCT Number: NCT04128917

Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

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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Key information

Conditions

Helicobacter Pylori Infection

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hosptial

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegoprazan

Drug

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

RAPAE01

Drug

RAPAE01/Clarithromycin/Amoxicillin BID peroral

Primary outcomes

  1. H. pylori eradication rate

    Time frame: Day 49

    Assess H. pylori eradication rate by UBT

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 16, 2019
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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