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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Livzon Pharmaceutical Group Inc.
• Treatments: Amoxicillin; Bismuth; Clarithromycin; Potassium Citrate

Criteria

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