Clinical trial NCT02401477: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Infections
Keywords: helicobacter pylori
ilaprazole
eradication
dual therapy
high dose therapy
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The eradication rate of H.pylori
timeFrame: Day 49±7
Secondary outcomes:
measure: The number of patients with Adverse Events
timeFrame: Day 49±7
Other outcomes:
Locations:
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
Study officials:
affiliation: DongGuk University
name: YoonJeong Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: