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The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

Primary Purpose

Peptic Ulcer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ilaprazole
Amoxicillin
Clarithromycin
Metronidazole
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 20 year old ≤ Male or female < 80 year old

    • Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.
    • Subject who fully understands conditions of clinical trial
    • Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

  • Known hypersensitivity to experimental and concomitant drugs
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.

  • Subjects with abnormal levels in the laboratory tests

    • Total Bilirubin, Creatinine> 1.5 times upper limit of normal
    • AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal
  • Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.
  • Pregnant and/or lactating women
  • Reproductive aged women not using contraception
  • Uncontrolled diabetics
  • Uncontrolled hypertension
  • Uncontrolled liver dysfunction
  • Alcoholics
  • Subjects with a history or possibility of digestive malignancy within 5 years
  • Subjects with a history of gastrectomy or esophagectomy
  • Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
  • Subjects participating in a clinical trial before another trial within 30 days
  • Inconsistence judged subject by researcher

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    triple with clarithromycin

    triple with metronidazole

    quadruple

    Arm Description

    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks

    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks

    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks

    Outcomes

    Primary Outcome Measures

    Eradication rate after tailored therapy assessed by urea breath test
    After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.

    Secondary Outcome Measures

    Number of participants with treatment-related adverse events as assessed by questionnaire
    During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.

    Full Information

    First Posted
    January 5, 2016
    Last Updated
    August 7, 2018
    Sponsor
    Kyungpook National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02648659
    Brief Title
    The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
    Official Title
    The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2016 (Actual)
    Primary Completion Date
    January 6, 2017 (Actual)
    Study Completion Date
    February 14, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kyungpook National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
    Detailed Description
    This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients. The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody. The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peptic Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    triple with clarithromycin
    Arm Type
    Experimental
    Arm Description
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
    Arm Title
    triple with metronidazole
    Arm Type
    Experimental
    Arm Description
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
    Arm Title
    quadruple
    Arm Type
    Experimental
    Arm Description
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ilaprazole
    Other Intervention Name(s)
    Noltec®
    Intervention Description
    Ilaprazole 10mg 1tablet qid(4 times/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin
    Other Intervention Name(s)
    Pamoxin®
    Intervention Description
    Amoxicillin 500mg 1capsule qid(4times/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Clarithromycin
    Other Intervention Name(s)
    Clafaxin®
    Intervention Description
    Clarithromycin 500mg 1tablet bid(2times/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Metronidazole
    Other Intervention Name(s)
    Flasinyl®
    Intervention Description
    Metronidazole 250mg 2tablets tid(3times/day)
    Primary Outcome Measure Information:
    Title
    Eradication rate after tailored therapy assessed by urea breath test
    Description
    After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.
    Time Frame
    Test at 4 -6 weeks after completion of medication
    Secondary Outcome Measure Information:
    Title
    Number of participants with treatment-related adverse events as assessed by questionnaire
    Description
    During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.
    Time Frame
    Questionnaire and diary during medication for 14days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • 20 year old ≤ Male or female < 80 year old Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test. Subject who fully understands conditions of clinical trial Subject who agrees to participate and spontaneously sign the ICF Exclusion Criteria: Known hypersensitivity to experimental and concomitant drugs Subjects who are taking contraindicated medications for experimental and concomitant drug. Subjects with abnormal levels in the laboratory tests Total Bilirubin, Creatinine> 1.5 times upper limit of normal AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study. Pregnant and/or lactating women Reproductive aged women not using contraception Uncontrolled diabetics Uncontrolled hypertension Uncontrolled liver dysfunction Alcoholics Subjects with a history or possibility of digestive malignancy within 5 years Subjects with a history of gastrectomy or esophagectomy Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption Subjects participating in a clinical trial before another trial within 30 days Inconsistence judged subject by researcher
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seong Woo Jeon
    Organizational Affiliation
    Kyungpook national university medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

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