KCT0004401已完成未知
A Multi-center, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of K-Cab (Tegoprazan) as Symptomatic Maintenance Therapy in Patients with NERD
Daegu Catholic University Medical Center0 个研究点目标入组 130 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
- 130
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 65(Year)（—）
- 性别
- All
入选标准
- •1. The age 19-65 years old
- •2. The patients who had a history of heartburn or regurgitation with a frequency of at least 2 episodes per week and diagnosed NERD of endoscopic finding (LA classification)
- •3. Wrritten informed consent was obtained from all participants
排除标准
- •1.The patients who cannot endoscopic examination
- •2.The patients who had an esophageal stricture, ulcer, reflus esophagitis, barret’s esophagus, active or healing stage peptic ulcer, gastrointestinal bleeding, and eosinophilic esophagitis
- •3.The patients who had gastrointestinal carcinoid tumor and history of endoscopic resection
- •4. patients who had an erosive reflux disease, gastrointestinal bleeding, active or healing stage peptic ulcer, gastritis, in the last 2 months.
- •5.History of drug and alcohol abuse
- •6.History of esophagus, stomach, duodenal surgery (exclusion, history of appendectomy and cholcystectomy)
- •7.History of malignancy in 5 years
- •8.History of allergy to antacid, proton pump inhibitor, potassium-competitive acid blocker and relating the clinical medication or silmilar drug
- •9.History of allergy to penicillin
- •10.Medication to perphenadine, cisapride, pymozid, astemizol
- •11.History of allergy to macrolide
- •12.who is being pregnant or lactating
- •13.Mental neuropathy patients (manic patients, etc.), alcoholics, drug dependence (central nervous system inhibitors, etc.)
- •14.Medication of HIV protease inhibitor or Rilpivirine ?? ??? ?? ?? ?
- •15.Abnormal serologic test
- •-over than UNL 2 or more times AST, ALT, ALP, ?-GT, total bilirubin
- •-over than UNL 1.5 or more times BUN, creatinine
- •16.Zollinger-Ellison syndrome patients
- •17.Patients with severe systemic disorders of the heart, lungs, blood and endocrine system
- •18. If the researcher judges that he / she is not suitable for participation other than the above items.
研究者
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