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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 : Recruiting
First Posted : October 23, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date November 28, 2017
Actual Study Start Date  ICMJE October 17, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03317223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: CJ-12420/Clarithromycin/Amoxicillin
    CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
    Intervention: Drug: CJ-12420/Clarithromycin/Amoxicillin
  • Active Comparator: Lansoprazole/Clarithromycin/Amoxicillin
    Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g
    Intervention: Drug: CJ-12420/Clarithromycin/Amoxicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ji Won Lee 82-2-6740-2385 jiwon.lee@cj.net
Contact: Eun Ji KIM 82-2-6740-2443 keunji@cj.net
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317223
Other Study ID Numbers  ICMJE CJ_APA_306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CJ HealthCare Corporation
Study Sponsor  ICMJE CJ HealthCare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yong Chan Lee Severance Hospital
PRS Account CJ HealthCare Corporation
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP