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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Helicobacter Pylori Eradication Antibiotic

Intervention / Treatment
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* Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
* Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid | Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy<br>* Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid<br>|
| Active Comparator: Active Comparator<br>Esoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid | Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy<br>* Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori as assessed by UBT test |  | up to 2 months |