Triple Therapy With Tegoprazan in H. Pylori Positive Patients

HK inno.N

Status and phase

Completed

Phase 3

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Tegoprazan/Amoxicillin/Clarithromycin

Drug: Lansoprazole/Amoxicillin/Clarithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03498456

CJ_APA_307

Details and patient eligibility

About

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.

Full 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.

Enrollment

284 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

H. pylori positive based on the screening test
Peptic ulcer disease

Exclusion criteria

Prior treatment for H. pylori eradication
Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days