K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections.

Kyungpook National University Medical Center0 个研究点目标入组 84 人开始时间: 待定最近更新: 2020年12月2日

适应症

试验速览

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•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)

•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

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