Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice and changing of health insurance law
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001980
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1137
1. Persons aged 19 and over
2. Patients who have undergone endoscopy within the last 3 months and who have been confirmed for Helicobacter pylori infection by biopsy or rapid urease test or urea breath test
3. Persons who agrees to participate in this study and who voluntarily signs the written consent
1. Previous history of helicobacter pylori eradication
2. Those who had undergone previous gastrectomy (excluding endoscopic resection)
3. Screening results showed that patients with clinically significant abnormalities and those with liver function abnormalities (more than three times the normal upper limit of AST or ALT) or renal abnormalities (according to [Appendix 3] Case)
4. Those who have a history of allergy to the test drug
5. Proton pump inhibitor within 2 weeks before the start of the test drug or who took histamine receptor antagonist within 1 week after the start of the test drug
6. Those who have taken the following medicines within one week prior to the start of the study drug or who need to take it during the test period: aspirin (provided that aspirin 100 mg or less per day for prophylactic antithrombotic use is not acceptable ), Oral or intravenous steroids, NSAIDs, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate)
7. Those who took antibiotics within 4 weeks before the start of the test drug
8. Pregnant women and lactating women, who are not fertile during pregnancy or who are not willing to use effective contraception during the test
9. Anyone who does not follow the scheduled visit schedule or fails the test procedure
10. Those who participated in other clinical trials within 3 months
11. Those who are taking one or more of the following drugs
(Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergot alkaloids and their derivatives(Ergotamine, Dihydroergotamine), Mizolastine, Bepridil, Ticagrelor)
12. Any person who is judged by the examiner to be in a condition that poses a health risk or interferes with the evaluation of the clinical trial subject
13. Those who have the following diseases : Patients with genetic problems such as infectious mononucleosis, central nervous system infected patients, patients with blood diseases or their history, patients with organic nervous system disease, galactosidosis and Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorders, patients with QT prolongation or ventricular arrhythmia (Including Torsades de pointes)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eradication rate
- Secondary Outcome Measures
Name Time Method the compliance and the adverse effects accordint to treatment regimen.