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Triple Therapy With Tegoprazan in H. Pylori Positive Patients

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ClinicalTrials.gov Identifier: NCT03498456
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE April 8, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2018)
H. pylori eradication rate [ Time Frame: 6 weeks ]
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03498456 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 Triple Therapy With Tegoprazan 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 Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
Brief Summary The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
Detailed Description This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. 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: Tegoprazan/Amoxicillin/Clarithromycin
    Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
    Other Name: Tegoprazan triple therapy (TAC)
  • Drug: Lansoprazole/Amoxicillin/Clarithromycin
    Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
    Other Name: Lansoprazole triple therapy (LAC)
Study Arms  ICMJE
  • Experimental: Tegoprazan/Amoxicillin/Clarithromycin
    Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
    Intervention: Drug: Tegoprazan/Amoxicillin/Clarithromycin
  • Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin
    Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
    Intervention: Drug: Lansoprazole/Amoxicillin/Clarithromycin
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: April 8, 2018)
284
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 6, 2020
Estimated Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • H. pylori positive based on the screening test
  • Peptic ulcer disease

Exclusion Criteria:

  • Prior treatment for H. pylori eradication
  • 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
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: Ah Rong Kim 82-2-6740-2441 ahrong.kim@cj.net
Contact: Eun Ji Kim 82-2-6740-2443 eunji.kim@cj.net
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498456
Other Study ID Numbers  ICMJE CJ_APA_307
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: Hwoon Yong Jung, Professor Asan Medical Center
PRS Account CJ HealthCare Corporation
Verification Date August 2018

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