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K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections.

Status Approved

  • First Submitted Date

    2020/06/22

  • Registered Date

    2020/07/06

  • Last Updated Date

    2020/11/27

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005202
    Unique Protocol ID 2020-03-027-001
    Public/Brief Title K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections.
    Scientific Title K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections.
    Acronym KCAB_006
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-03-027-001
    Approval Date 2020-04-23
    Institutional Review Board Name Kyungpook National University Medical Center Institutional Review Board
    Institutional Review Board Address 807, Hoguk-ro, Buk-gu, Daegu
    Institutional Review Board Telephone 053-200-2162
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Yong Hwan Kwon
    Title Assistant Professor
    Telephone +82-53-200-3077
    Affiliation Kyungpook National University Medical Center
    Address Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea
    Contact Person for Public Queries
    Name Yong Hwan Kwon
    Title Assistant Professor
    Telephone +82-53-200-3077
    Affiliation Kyungpook National University Medical Center
    Address Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea
    Contact Person for Updating Information
    Name Yong Hwan Kwon
    Title Assistant Professor
    Telephone +82-53-200-3077
    Affiliation Kyungpook National University Medical Center
    Address Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-10-13 Actual
    Target Number of Participant 84
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Kyungpook National University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2020-10-13 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name CJ Healthcare
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyungpook National University Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Various treatment strategies with antibiotics and proton pump inhibitors (PPIs) have been proposed for eradication of Helicobacter pylori infection. Initial approach with traditional triple therapy is considered ineffective as eradication rate of that is only approximately 70%. The eradication rate of the recently proposed concomitant therapy, which consists of clarithromycin, metronidazole, amoxicillin, and PPI, is greater than 90% owing to its low prevalence of antibiotic resistance. For successful eradication, it is important to take both antibiotic resistance and role of PPI into account. PPIs maintain gastric pH to be greater than 6 so that antibiotics can take effect. Pre-existing PPIs have short half-life, and rapid metabolizers to pre-existing PPIs are frequently found in Asian population. Potassium-competitive acid blocker (P-CAB), a recently developed new class of acid blocker, suppresses gastric acid through a different mechanism compared to that of PPIs, and duration time is similar. Therefore, we hypothesized that P-CAB would be effective in H. pylori eradication. This study aims to validate the efficacy of P-CAB (tegoprazan) based concomitant 10-day therapy in the H. pylori eradication in a single arm group.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description
    Tegoprazan-based concomitant therapy (twice-daily administration of tegoprazan 50mg, amoxicillin 1000mg, clarithromycin 500mg, metronidazole 500mg) for 10 days to patients tested positive for H. pylori
    Number of Arms 1
    Arm 1

    Arm Label

    Treatment group with tegoprazan-based concomitant therapy for 10 days

    Target Number of Participant

    84

    Arm Type

    Experimental

    Arm Description

    Oral administration of tegoprazan-based concomitant therapy (twice-daily administration of tegoprazan 50mg, amoxicillin 1000mg, clarithromycin 500mg, metronidazole 500mg) for 10 days
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (A00-B99)Certain infectious and parasitic diseases 
       (B98.0)Helicobacter pylori[H.pylori] as the cause of diseases classified to other chapters 

    Helicobacter pylori infection
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~80Year

    Description

    1. Male or female, aged 20- to 80-year-old 
    2. Patients who underwent upper gastrointestinal endoscopy tested positive for H. pylori, defined as 2 or more of the following tests resulted positive: rapid urease test, biopsy, serum antibody test (IgG, HP antibody)
    3. Subjects who can understand the details of the study
    4. Subjects who agreed to participate in this study, and signed voluntarily to written consent
    5. Subjects who agreed to use medically appropriate contraception methods during clinical trial period (including patients that are medically incapable of conception)
    - Subjects that are medically incapable of conception: post-menopausal women (amenorrhea for at least 24 months), patients who underwent hysterectomy, oophorectomy, or salpingectomy
    - Medically appropriate contraception: intrauterine devices (e.g., loop, Mirena ®), physical intervention (condoms for male and female), subcutaneous implant (e.g. Implanon ®), contraceptive injection (e.g. Depo-Provera ®), tubectomy or vasectomy, etc. (Oral contraceptives are not applicable during this clinical trial, and dual methods for contraception recommended to ascertain contraception)
    Exclusion Criteria
    1. Patients with prior history of hypersensitivity to drugs administered in this trial, or to principal components or pharmaceutical excipients to penicillin or macrolide
    2. Patients who are using drugs that are incompatible or contraindicated to the drugs administered in this trial
    3. Patients who showed following abnormal laboratory results
    - That exceeds 2-fold increase in the upper normal limit of AST, ALT, ALP, γ-GT, or total bilirubin
    - That exceeds 1.5-fold increase in the upper normal limit of BUN, Cr
    4. Patients who were treated with PPI within 2 weeks or antibiotics within 4 weeks prior to trial
    5. Pregnant or breastfeeding women
    6. Patients with uncontrolled diabetes, hypertension, or abnormal liver function
    7. Alcohol abusers
    8. Patients with history of gastrointestinal malignancy within 5 years (gastric adenoma or endoscopic resection of early gastric cancer excluded) 
    9. Patients with history of esophagectomy or gastrectomy
    10. Patients with history of genetic diseases relevant to galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
    11. Patients with prior history of H. pylori eradication
    12. Subjects who participated in other clinical trials within 30 days to initiation of this trial
    13. Subjects who are considered unsuitable for this trial by investigators
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Eradication rate of H. pylori after tegoprazan-based concomitant 10-day therapy
    Timepoint
    52~59 days after prescription of trial medication
    Secondary Outcome(s) 1
    Outcome
    Eradication rate of H. pylori according to the resistance of each antibiotic (amoxicillin, clarithromycin, metronidazole)
    Timepoint
    3 months after administration of drug
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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