A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
研究概览
简要总结
This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP". The intended use is to reduce the GastroEsophageal Reflux Disease (GERD) symptoms such as heartburn, epigastric pain, irritative and nocturnal cough, dysphagia and dysphonia, which may occur especially after meals or during the night due to lying position. "FIBROIN SYRUP" has never been tested on humans and this study aims to evaluate the safety, tolerability and efficacy of the medical device when taken after the main meals (breakfast, lunch, and dinner; total: 3 sticks/day) for 6 weeks.
详细描述
This study requires 4 outpatient visits in 6 weeks and it is addressed to patients over 18 years old suffering from heartburn and/or regurgitation for at least 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who signed Informed consent form;
- •Male or Female over 18 years old at the time of the signature of the Informed consent form;
- •Symptomatic non-erosive reflux disease (heartburn and/or regurgitation) for at least 8 weeks;
- •RDQ (Reflux Disease Questionnaire) score ≥ 12 at baseline (questionnaire specific for reporting the frequency and severity of upper gastrointestinal symptoms);
- •Willingness to follow all study procedures, including attending all site visits, tests and examinations.
排除标准
- •Esophagitis according to the Los Angeles classification (grade A to D);
- •Diagnosis of Helicobacter pylori infection;
- •Use of proton pump inhibitors or H2 receptor antagonists in the previous 4 weeks;
- •Uncontrolled cardiac, renal, liver or pulmonary disease;
- •Diabetes;
- •Active malignant neoplasia;
- •Pregnancy or breast-feeding;
- •Known allergy to device components;
- •Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion;
- •Known drug and/or alcohol abuse;
- •Mental incapacity that precludes adequate understanding or cooperation.
研究组 & 干预措施
Adult patients suffering from gastroesophageal reflux disease
干预措施: Syrup made by hyaluronic acid (Device)
结局指标
主要结局
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
时间窗: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg)
次要结局
- To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.(V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0))
- To evaluate the patient's satisfaction(V2 (12 weeks form V0))
- The Safety and the tolerability will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.(V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0))
- To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.(V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0))