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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

350 participants in 2 patient groups

CJ-12420/Clarithromycin/Amoxicillin
Experimental group
Description:
CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
Treatment:
Drug: CJ-12420/Clarithromycin/Amoxicillin
Lansoprazole/Clarithromycin/Amoxicillin
Active Comparator group
Description:
Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g
Treatment:
Drug: CJ-12420/Clarithromycin/Amoxicillin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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