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

Livzon Pharmaceutical Group

Status and phase

Completed

Phase 4

Conditions

Helicobacter Pylori Eradication Antibiotic

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02835560

Livzon-IY-81149R

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.