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

NCT ID: NCT05933031

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan 50 mg

Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Group Type EXPERIMENTAL

Tegoprazan 50 mg Triple Therapy

Intervention Type DRUG

Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Tegoprazan 100 mg

Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Group Type EXPERIMENTAL

Tegoprazan 100 mg Triple Therapy

Intervention Type DRUG

Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Lansoprazole

Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days

Group Type ACTIVE_COMPARATOR

Lansoprazole Triple Therapy

Intervention Type DRUG

Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

Interventions

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Tegoprazan 50 mg Triple Therapy

Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Intervention Type DRUG

Tegoprazan 100 mg Triple Therapy

Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Intervention Type DRUG

Lansoprazole Triple Therapy

Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Gyu Kim

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

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Chung-Ang University Hosptial

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eun Ji Kim

Role: CONTACT

82-2-6477-0290

Hee Hyun Kim

Role: CONTACT

82-2-6477-0258

Other Identifiers

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IN_APA_E02

Identifier Type: -

Identifier Source: org_study_id

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