Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

May 10, 2021 updated by: HK inno.N Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tegoprazan 50 mg
Tegoprazan 50 mg Triple Therapy
Drug: Tegoprazan
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
Experimental: Tegoprazan 100 mg
Tegoprazan 100 mg Triple Therapy
Drug: Tegoprazan
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
Active Comparator: RAPAE01
RAPAE01 Triple Therapy
Drug: RAPAE01
RAPAE01/Clarithromycin/Amoxicillin BID peroral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H. pylori eradication rate
Time Frame: Day 49
Assess H. pylori eradication rate by UBT
Day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: JAEGYU KIM, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Actual)

December 21, 2020

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CJ_APA_E01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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