NCT05933031

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Tegoprazan 50 mg Triple Therapy	Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
DRUG	Tegoprazan 100 mg Triple Therapy	Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
DRUG	Lansoprazole Triple Therapy	Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

Timeline

• Start date: 2023-02-27
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-06
• Last updated: 2023-07-06

Locations

1 site across 1 country: South Korea