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

• Status: Completed
• Trial end date: 2019-01-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Amoxicillin; Clarithromycin; Dexlansoprazole; Lansoprazole

Criteria

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