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

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: CJ-12420/Clarithromycin/Amoxicillin

• Registration Number: NCT03317223
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Primary Completion: 2019-01-21
• Study Completion: 2019-01-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• H. pylori-positive at screening
• Complain of gastric discomfort symptom

Exclusion Criteria

• Having received prior therapy for eradication of H. pylori
• 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
CJ-12420/Clarithromycin/Amoxicillin	CJ-12420/Clarithromycin/Amoxicillin	CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
Lansoprazole/Clarithromycin/Amoxicillin	CJ-12420/Clarithromycin/Amoxicillin	Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	twice a day	Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment)

Trial Locations

Locations (1)

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of