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NCT03317223 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03317223
Other study ID # CJ_APA_306
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 17, 2017
Est. completion date January 24, 2019

Study information
Verified date October 2021
Source HK inno.N Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date January 24, 2019
Est. primary completion date January 21, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days

Locations
Country Name City State
Korea, Republic of Yonsei University Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment) twice a day
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