Helicobacter Infections
Conditions
Keywords
helicobacter pylori, ilaprazole, eradication, dual therapy, high dose therapy
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.
Interventions
DRUGIlaprazole + Amoxicillin
Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
Sponsors
Il-Yang Pharm. Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The number of patients with Adverse Events | Day 49±7 |
Countries
South Korea
Outcome results
None listed