NCT03317223

A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 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 CJ-12420, Amoxicillin and Clarithromycin in H. Pylori Positive Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (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 CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.

Detailed description

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	CJ-12420/Clarithromycin/Amoxicillin	CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days

Timeline

• Start date: 2017-10-17
• Primary completion: 2019-01-21
• Completion: 2019-01-24
• First posted: 2017-10-23
• Last updated: 2021-10-18

Locations

1 site across 1 country: South Korea