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Completed

NCT Number: NCT03317223

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University Severance Hospital

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CJ-12420/Clarithromycin/Amoxicillin

Drug

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

Other names: Lansoprazole/Clarithromycin/Amoxicillin

Primary outcomes

  1. H. pylori eradication rate

    Time frame: twice a day

    Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment)

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2017
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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