Overview

Triple Therapy With Tegoprazan in H. Pylori Positive Patients

Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CJ HealthCare Corporation
HK inno.N Corporation
Treatments:
Amoxicillin
Clarithromycin
Dexlansoprazole
Lansoprazole
Criteria
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