Status:
COMPLETED
A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
Lead Sponsor:
HK inno.N Corporation
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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, amo...
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 ask...
Eligibility Criteria
Inclusion
- H. pylori-positive at screening
- Complain of gastric discomfort symptom
Exclusion
- 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
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2019
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03317223
Start Date
October 17 2017
End Date
January 24 2019
Last Update
October 18 2021
Active Locations (1)
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1
Yonsei University Severance Hospital
Seoul, South Korea, 03722