Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection

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

Summary

This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.

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

Details

• Lead Sponsor: Il-Yang Pharm. Co., Ltd.
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.

• 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(Penicillin Antibiotics).

• 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

• Uncontrolled kidney dysfunction

• Alcoholics

• Subjects with a history or possibility 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.

• Infectious mononucleosis patients

• Subjects participating in a clinical trial before another trial wihin 30 days

• Inconsistence judged subject by researcher