Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori

Livzon Pharmaceutical Group

Status and phase

Completed

Phase 4

Conditions

Helicobacter Pylori Eradication

Treatments

Drug: Esoprazole

Drug: Ilaprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02873065

LivzonIY-81149R-11-02

Details and patient eligibility

About

This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Full description

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 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，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

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, Esoprazole, Amoxicillin and Clarithromycin
Subjects who are taking contraindicated medications for experimental and concomitant drug
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
Alcoholics
Subjects with a history of digestive malignancy within 5 years
Subjects with a history of gastrectomy or esophagectomy
Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
Subjects participating in a clinical trial before another trial within 30 days
Inconsistent judged subject by researcher