None listed
Conditions
Interventions
Drug : Tegoprazan-based concomitant therapy (twice-daily administration of tegoprazan 50mg, amoxicillin 1000mg, clarithromycin 500mg, metronidazole 500mg) for 10 days to patients tested positive for H
Sponsors
Kyungpook National University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 20- to 80-year-old 2. Patients who underwent upper gastrointestinal endoscopy tested positive for H. pylori, defined as 2 or more of the following tests resulted positive: rapid urease test, biopsy, serum antibody test (IgG, HP antibody) 3. Subjects who can understand the details of the study 4. Subjects who agreed to participate in this study, and signed voluntarily to written consent 5. Subjects who agreed to use medically appropriate contraception methods during clinical trial period (including patients that are medically incapable of conception) - Subjects that are medically incapable of conception: post-menopausal women (amenorrhea for at least 24 months), patients who underwent hysterectomy, oophorectomy, or salpingectomy - Medically appropriate contraception: intrauterine devices (e.g., loop, Mirena ®), physical intervention (condoms for male and female), subcutaneous implant (e.g. Implanon ®), contraceptive injection (e.g. Depo-Provera ®), tubectomy or vasectomy, etc. (Oral contraceptives are not applicable during this clinical trial, and dual methods for contraception recommended to ascertain contraception)
Exclusion criteria
Exclusion criteria: 1. Patients with prior history of hypersensitivity to drugs administered in this trial, or to principal components or pharmaceutical excipients to penicillin or macrolide 2. Patients who are using drugs that are incompatible or contraindicated to the drugs administered in this trial 3. Patients who showed following abnormal laboratory results - That exceeds 2-fold increase in the upper normal limit of AST, ALT, ALP, ?-GT, or total bilirubin - That exceeds 1.5-fold increase in the upper normal limit of BUN, Cr 4. Patients who were treated with PPI within 2 weeks or antibiotics within 4 weeks prior to trial 5. Pregnant or breastfeeding women 6. Patients with uncontrolled diabetes, hypertension, or abnormal liver function 7. Alcohol abusers 8. Patients with history of gastrointestinal malignancy within 5 years (gastric adenoma or endoscopic resection of early gastric cancer excluded) 9. Patients with history of esophagectomy or gastrectomy 10. Patients with history of genetic diseases relevant to galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 11. Patients with prior history of H. pylori eradication 12. Subjects who participated in other clinical trials within 30 days to initiation of this trial 13. Subjects who are considered unsuitable for this trial by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate of H. pylori after tegoprazan-based concomitant 10-day therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Eradication rate of H. pylori according to the resistance of each antibiotic (amoxicillin, clarithromycin, metronidazole) | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Hwan Kwon
Kyungpook National University Medical Center
Outcome results
None listed