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

HK inno.N

Status and phase

Completed

Phase 3

Conditions

Helicobacter Pylori Infection

Treatments

Drug: CJ-12420/Clarithromycin/Amoxicillin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03317223

CJ_APA_306

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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