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

NCT ID: NCT02401477

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed Description

The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.

Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.

Conditions

Helicobacter Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ilaprazole + Amoxicillin

Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days

Group Type: EXPERIMENTAL

Ilaprazole + Amoxicillin

Intervention Type: DRUG

Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule

Interventions

Ilaprazole + Amoxicillin

Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule

Intervention Type: DRUG

Other Intervention Names

Ilaprazole; Amoxicillin

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Il-Yang Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YoonJeong Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Locations

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

DUMC-LYJ-ILA01

Identifier Type: -

Identifier Source: org_study_id