KCT0005723已完成未知
Efficacy of tegoprazan based bismuth quadruple therapy compared with bismuth quadruple therapy for Helicobacter pylori infection: Randomized, Double-blind, Active-Controlled Study
The Catholic University of Korea, Incheon St. Mary's Hospital0 个研究点目标入组 216 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection
- •- helicobacter gastrits, atrophic gastritis, family history of gastric cancer
- •- peptic ulcer
- •- gastric MATL lymphoma(Extraodal marginal zone B cell lymphoma of MALT)
- •- patients diagnosed with early gastric cancer or gastric adenoma and underwent endoscopic submucosal dissection (ESD)
排除标准
- •1. patients who have H.pylori eradication history
- •2. patients with history of gastric cancer surgery
- •3. patients with history of gastrointestinal malignancy within 5 years(gastric cancer excluded)
- •4. pateints with severe liver failure
- •5. patients with hematologic disorders or history
- •6. patients with central nervous system infection or organic neurological disorders(including hypothyroidism, hypoadreno corticism)
- •7. patients with infectious mononucleosis
- •8. patients with renal disorder or renal failure
- •9. patients who have taken antibiotics within 4 weeks prior to trial
- •10. patients who have a history or hypersensitivity reaction(hypersensitivity reactions of anaphylaxis, anaphylaxis shock, angioedema, bronchospasm, acute tubulo-interstitial nephritis and allergy) to investigational products(tegoprazan, benzimidazole, penicillin, macrolide, imidazole derivatives, tetracycline)
- •11. a person who taking terfenadine,cisapride, pimozide, astemizole
- •12. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
- •13. patients who are taking contraindicated drugs(Indinavir, Ritonavir, Cyclosporin, Terfenadine, cisapride, Pimozide, Astemizole, HIV protease inhibitors(Atazanavir, Nelfinavir) Ergot alkaloids and derivatives(Ergotamine, Dihydroergotamine), Mizolastine, Bepridil, Ticagrelor, Retinoids (isotretinoin and etcs)
- •14. patients with ongoing alcohol metabolism(who have taken disulfiram within 2 weeks prior to trial)
- •15. pregnant or breastfeeding women
- •16. patients with genetic problems such as galactose intolerance and Lapp lactose deficiency or glucose-galactose uptake, QT prolongation or ventricular arrhythmia(including Torsades de pointes) history
- •17. 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
研究者
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