Helicobacter Pylori Eradication Antibiotic
Conditions
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.
Interventions
DRUGIlaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid
DRUGEsoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Livzon Pharmaceutical Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate of Helicobacter pylori as assessed by UBT test | up to 2 months |
Outcome results
None listed