Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients

July 3, 2023 updated by: HK inno.N Corporation

A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients

This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.

Study Type

Interventional

Enrollment (Estimated)

381

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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/Clarithromycin/ Amoxicillin BID peroral, 14 days
Drug: Tegoprazan 50 mg Triple Therapy
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Experimental: Tegoprazan 100 mg
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Drug: Tegoprazan 100 mg Triple Therapy
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Active Comparator: Lansoprazole
Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
Drug: Lansoprazole Triple Therapy
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H. pylori eradication rate
Time Frame: 42 days
Assess H. pylori eradication rate by UBT
42 days

Collaborators and Investigators

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

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Jae Gyu 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)

February 27, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN_APA_E02

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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