search
Back to results

Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Eradication Antibiotic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
Sponsored by
Livzon Pharmaceutical Group Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Eradication Antibiotic

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
  • Subject who fully understands conditions of clinical trial.
  • Subject who agrees to participate and spontaneously sign the ICF.

Exclusion Criteria:

  • Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin.
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • Patients 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 4 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Active Comparator

    Arm Description

    Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid

    Esoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid

    Outcomes

    Primary Outcome Measures

    Eradication rate of Helicobacter pylori as assessed by UBT test

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2016
    Last Updated
    July 15, 2016
    Sponsor
    Livzon Pharmaceutical Group Inc.
    Collaborators
    Fifth Affiliated Hospital, Sun Yat-Sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02835560
    Brief Title
    Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
    Official Title
    Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Livzon Pharmaceutical Group Inc.
    Collaborators
    Fifth Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori. Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
    Detailed Description
    This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori. Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Helicobacter Pylori Eradication Antibiotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid
    Arm Title
    Active Comparator
    Arm Type
    Active Comparator
    Arm Description
    Esoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
    Intervention Description
    Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
    Intervention Description
    Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
    Primary Outcome Measure Information:
    Title
    Eradication rate of Helicobacter pylori as assessed by UBT test
    Time Frame
    up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. Subject who fully understands conditions of clinical trial. Subject who agrees to participate and spontaneously sign the ICF. Exclusion Criteria: Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin. Subjects who are taking contraindicated medications for experimental and concomitant drug. Patients 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 4 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection

    We'll reach out to this number within 24 hrs