KCT0005160招募中未知
A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of K-CAB (tegoprazan) in patients with laryngopharyngeal reflux disease: A Pilot study
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 36
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 o Limit（—）
- 性别
- All
入选标准
- •1. age > 19
- •2. Sx of LPRD(hoarsness, frequent throat clearing, globus, sore throat or chronic cough)
- •3. RSI = 13, RFS = 7
- •4. Patient who understand given information and write questionnaire.
- •5. Those who voluntarily decide to participate in this clinical trial and give written consent
排除标准
- •1. viral or bacterial laryngopharyngitis
- •2. patient who had history of malignancy in pharynx/larynx/esophagus/stomach
- •3. A person who has had radiation therapy in the neck area in the past or has had a bronchial intubation within the last 3 months.
- •4.Those who have undergone gastric acid suppression surgery or gastric and esophageal surgery (except simple perforation surgery, appendectomy, and benign tumor resection using an endoscope)
- •5. People with bipolar disorder, anxiety disorders, airport disorders, somatoform disorders, personality disorders, and other psychiatric disorders
- •6. People taking antipsychotic drugs, antidepressants, or anti-anxiety drugs
- •7. Those who have taken gastric acid inhibitors such as proton pump inhibitor (PPI) within the last 4 weeks as of Visit 1
- •8. Patients who have taken medications related to gastroesophageal reflux disease (H2 receptor blockers, prostaglandins, mucosal protection, gastrointestinal motility, etc.) within the last 2 weeks as of Visit 1
- •9. Patients who need to take non-steroidal anti-inflammatory drugs continuously during the test period (however, low-dose [100 mg or less per day] aspirin taken for preventive purposes before participation in clinical trials is permitted)
- •10. Pregnant women, lactating women or women of childbearing potential who did not agree to use the appropriate contraceptive method during the trial period (? Appropriate contraceptive methods: condoms, oral contraceptives, injectable or injectable contraceptives, intrauterine contraceptives installed, etc.)
- •11. A person who showed clinically significant abnormality in the screening test
- •-AST, ALT, ALP, ?-GT, total bilirubin levels are more than twice the upper limit
- •-BUN and creatinine levels are more than 1.5 times the upper limit
- •12. Patients with clinically significant abnormal ECG
- •-Major arrhythmia, multifocal PVC, 2°AV-block or more
- •13. Those who have a history of malignant tumors within the last 5 years (however, those who have been judged to have complete remission of the tumor and have passed more than 5 years without recurrence from the date of determination, and tumors removed through endoscopic resection within 3 years) Those without this are excluded)
- •14. Those who have clinically significant disorders in the liver, kidneys, cardiovascular system, respiratory system, endocrine system, and central nervous system
- •15. A person with a history of hypersensitivity to an allergic disease or component of a test drug or a specific drug
- •16. A person who has received another clinical trial drug within 3 months from the time of written consent.
- •17. Those who are judged not to be suitable for this clinical trial by the investigator's judgment
- •18. Persons who are receiving atazanavir, nelfinavir, or lilipyrin-containing preparations
研究者
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