Triple Therapy With Tegoprazan in H. Pylori Positive Patients

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498456
• Other study ID #: CJ_APA_307
• Status: Completed
• Phase: Phase 3
• Start date: June 28, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate	Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.	6 weeks