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

Primary Purpose

Helicobacter Infections

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ilaprazole + Amoxicillin
Sponsored by
Il-Yang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Infections focused on measuring helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongguk University Ilsan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ilaprazole + Amoxicillin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The number of patients with Adverse Events

Full Information

First Posted
March 24, 2015
Last Updated
November 2, 2015
Sponsor
Il-Yang Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02401477
Brief Title
Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection
Official Title
Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infections
Keywords
helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilaprazole + Amoxicillin
Arm Type
Experimental
Arm Description
Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days
Intervention Type
Drug
Intervention Name(s)
Ilaprazole + Amoxicillin
Other Intervention Name(s)
Ilaprazole, Amoxicillin
Intervention Description
Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
Primary Outcome Measure Information:
Title
The eradication rate of H.pylori
Description
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.
Time Frame
Day 49±7
Secondary Outcome Measure Information:
Title
The number of patients with Adverse Events
Time Frame
Day 49±7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YoonJeong Lim, MD, PhD
Organizational Affiliation
DongGuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si, Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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