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

Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Infections
• Intervention / Treatment: Drug: Ilaprazole + Amoxicillin

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Goyang-si, Gyeonggi-do, Korea, Republic of
    • Dongguk University Ilsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ilaprazole + Amoxicillin; Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days	Drug: Ilaprazole + Amoxicillin; Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule; Other Names: Amoxicillin; Ilaprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The eradication rate of H.pylori	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.	Day 49±7

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients with Adverse Events	Day 49±7

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Principal Investigator: YoonJeong Lim, MD, PhD, DongGuk University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: dual therapy; helicobacter pylori; eradication; high dose therapy; ilaprazole
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: DUMC-LYJ-ILA01