KCT0007562终止未知
A Multi-center, Open-label, Single arm, Investigator Initiated Trial to Evaluate the Efficacy and Safety of FEXUCLUE40mg(Fexuprazan hydrochloride) in Patients with Non-Erosive Reflux Disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 100
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
- •1. Adult male and female directors aged 19 to 75 years old based on the date of acquisition of written consent form
- •2. A person whose Esophago gastro Duodenoscopy (EGD) examination performed by the same institution within 14 days of Visit 1 or Visit 1 did not observe mucosal break according to the Los-Angels grade
- •3. A person who has complained of heartburn (a heartburn or burning sensation inside the breastbone, a pain inside the breastbone) or acid reflux (a symptom of the overcoming of the body or reflux of stomach contents into the esophagus) from 3 months prior to Visit 1
- •4. As a result of the Reflux Disease Questionnaire (RDQ) evaluation at Visit 2, those who have experienced heartburn or acid reflux for at least 1 day in the last 7 days
- •5. person who can understand the information provided to him or her and who can complete the questionnaire and the test subject's diary (ePRO)
- •6. A person who voluntarily decides to participate in this clinical trial and agrees in writing
排除标准
- •[ Related to Digestive System]
- •1. Screening Esophago gastro Duodenoscopy, Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, gastrointestinal bleeding, and malignant tumors
- •2. Patients diagnosed with erosive gastroesophageal reflux disease, acute upper gastrointestinal bleeding, gastric ulcer or duodenal ulcer within 2 months based on Visit 1
- •3. Those diagnosed with functional dyspepsia (FD), primary esophageal motility disorder, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD) within 3 months based on Visit 1
- •4. Patients who have undergone gastric acid secretion suppression or gastroesophageal surgery (e.g., gastrectomy, gastrectomy, etc.)
- •(Excluding simple perforation surgery and benign tumor resection using an endoscope)
- •5. A person who has warning symptoms (laternal pain, severe dysfunction, bleeding, weight loss, anemia, and bloody stool) that can estimate a malignant disease of the gastrointestinal tract
- •(However, a person who shows additional warning symptoms to a typical gastroesophageal reflux disease may be included if the tumor is confirmed to be negative by endoscopy, etc.)
- •6. a patient with Zollinger-Ellison syndrome
- •7. patients with eosinophilic esophagitis
- •(However, it may be included if esophageal biopsy determines that it is not eosinophilic esophagitis.)
- •[Medical History]
- •8. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose absorption disorder
- •9. Those who have a clinically significant disease (liver, kidney, nervous system, respiratory system, endocrine system, blood·tumor, cardiovascular system, and urology)
- •10. A person with a history of malignancy within 3 years based on Visit 1
- •(However, in the case of malignant tumors other than those of the digestive system, those who have been cured and have passed more than three years without recurrence from the date of judgment can register.)
- •11. In Visit 1, people with bipolar disorder, anxiety disorder, panic disorder, body type disorder, personality disorder, or other clinically significant psychiatric disorders
- •12. Those who have a history of alcohol and other substance abuse within 1 year based on Visit 1
- •13. A person who has a history of hypersensitivity or clinically significant hypersensitivity reactions to the components of a drug
- •14. Those with acquired immunodeficiency syndrome (AIDS) or hepatitis (including HBs antigen-positive or HCV antibody-positive or hepatitis virus carriers)
- •(However, HCV-RNA negative test subjects can participate)
- •[Medication/Therapy history]
- •15. A person who has taken the following medication within two weeks prior to screening Esophago gastro Duodenoscopy or needs to be taken continuously during the clinical trial period*
- •(However, registration is possible if the selection criteria for endoscopic findings performed after sufficient wash-out (one week or two weeks for NSAIDs with a half-life of more than 24 hours) are satisfied if the following drugs are taken.)
- •- Nonsteroidal anti-inflammatory analgesics (aspirin, etc.) and acetaminophen
- •: Allow low doses of aspirin (below 100 mg/day) that have been taken for preventive purposes prior to clinical participation
- •: Acetaminophen can be taken up to 4g per day and should not exceed 5 days in total during 4 weeks
- •- Acid secretion inhibitors: proton pump inhibitors (PPI), potassium competitive gastric acid secretion inhibitors (P-CAB), H
研究者
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