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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02401477
Other study ID # DUMC-LYJ-ILA01
Secondary ID
Status Completed
Phase Phase 4
First received March 24, 2015
Last updated November 2, 2015
Start date December 2014
Est. completion date June 2015

Study information

Verified date November 2015
Source Il-Yang Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 80 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary The number of patients with Adverse Events Day 49±7 Yes
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