Triple Therapy With Tegoprazan in H. Pylori Positive Patients

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Tegoprazan/Amoxicillin/Clarithromycin; Drug: Lansoprazole/Amoxicillin/Clarithromycin

• Registration Number: NCT03498456
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-08
• Study First Posted: 2018-04-13
• Study Start: 2018-06-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegoprazan/Amoxicillin/Clarithromycin	Tegoprazan/Amoxicillin/Clarithromycin	Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Lansoprazole/Amoxicillin/Clarithromycin	Lansoprazole/Amoxicillin/Clarithromycin	Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	6 weeks	Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of