Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter pylori in Korea
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0001176
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 390
1) Male and female Korean Adult (Aged = 18 years)
2) Patients who diagnosis of H. pylori infection by any of following three methods
? positive rapid urease test (CLOtest)
? histologic evidence of H. pylori by modified Giemsa staining
? positive 13C-urea breath test
3) Subjects who want to participate this clinical trial and have signed the
informed consent document
4) Subject who understand and complete all the questions on the questionnaires
1) Age under 18 years
2) Previous eradication treatment for H. pylori
3) Patients who took any drug which could influence the study results such as
proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
4) History of gastrectomy
5) Advanced gastric cancer or other malignancy
6) Abnormal liver function or liver cirrhosis
7) Abnormal renal function or chronic kidney disease
8) Other severe concurrent diseases
9) Previous contraindication or allergic reactions to the study drugs
10)Patients with genetic disorder - galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
11)Patients with mental disorder, alcohol or drug addiction
12)Pregnant or lactating women or women who disagree to use an appropriate method of contraception through the course of this study
13)Patients who has some conditions to affect the evaluation of the clinical results by the judgement of the principal investigator or sub-investigator
14)Specific contraindication to the study drugs
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the percentage of participants with successful H. pylori eradication in each groups
- Secondary Outcome Measures
Name Time Method Compare the percentage of patients whose drug compliance is more than 85% and the percentage of adverse event in each treatment groups;Compare the percentage of adverse event in each treatment groups;Change from baseline in functional dyspepsia symptom on the 5-Likert scale