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NCT05933031 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05933031
Other study ID # IN_APA_E02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 27, 2023
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source HK inno.N Corporation
Contact Eun Ji Kim
Phone 82-2-6477-0290
Email eunji.kim24@inno-n.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 381
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tegoprazan 50 mg Triple Therapy
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
• Tegoprazan 100 mg Triple Therapy
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
• Lansoprazole Triple Therapy
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

Locations
Country Name City State
Korea, Republic of Chung-Ang University Hosptial Seoul

Sponsors (1)
Lead Sponsor Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate Assess H. pylori eradication rate by UBT 42 days
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