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

Phase 4

Completed

• Conditions: Helicobacter Infections
• Interventions: Drug: Ilaprazole + Amoxicillin

• Registration Number: NCT02401477
• Lead Sponsor: Il-Yang Pharm. Co., Ltd.

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The eradication rate of H.pylori	Day 49±7	The eradication rate of H.pylori after 14 days 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 treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.

Secondary Outcome Measures

Name	Time	Method
The number of patients with Adverse Events	Day 49±7

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of