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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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ClinicalTrials.gov Identifier: NCT03317223
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: CJ-12420/Clarithromycin/Amoxicillin Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
Drug: CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Other Name: Lansoprazole/Clarithromycin/Amoxicillin

Active Comparator: Lansoprazole/Clarithromycin/Amoxicillin
Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g
Drug: CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Other Name: Lansoprazole/Clarithromycin/Amoxicillin




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 antibiotis, bismuth within 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317223


Locations
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Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Yong Chan Lee Severance Hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03317223     History of Changes
Other Study ID Numbers: CJ_APA_306
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clarithromycin
Amoxicillin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors