NCT03498456

Triple Therapy With Tegoprazan in H. Pylori Positive Patients

A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.

Detailed description

This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Tegoprazan/Amoxicillin/Clarithromycin	Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
DRUG	Lansoprazole/Amoxicillin/Clarithromycin	Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.

Timeline

• Start date: 2018-06-28
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-04-13
• Last updated: 2020-05-08

Locations

1 site across 1 country: South Korea