Status:
COMPLETED
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Collaborating Sponsors:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Helicobacter Pylori Eradication Antibiotic
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02835560
Start Date
June 1 2013
Last Update
July 18 2016
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