NCT03883074已完成不适用
Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study
SOFAR S.p.A.2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Esophageal Impedance
研究概览
简要总结
The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, age 18 to 75 years
- •GERD as defined by an acid exposure time >4% on pH/impedance monitoring and/or esophagitis LA grade A or B on endoscopy
- •Heartburn at least twice per week over the last 1 month
- •ReQuest Symptoms sum score >3,37 at screening
- •GERD patients not treated with a PPI in the previous 2 months
- •Subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent
排除标准
- •Patients suffering from gastrointestinal diseases other than GERD
- •Esophagitis LA grade C or D or Barrett's esophagus on endoscopy
- •Impaired kidney or liver function
- •Significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator
- •Medication use (including NSAIDS) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
- •Pregnancy or breast-feeding
- •Females of childbearing potential in the absence of effective contraceptive methods
- •History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
- •History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
- •Treatment with any investigational drug within the previous 30 days
- •Active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment)
- •Inability to conform to protocol procedures
结局指标
主要结局
Esophageal Impedance
时间窗: 3 weeks
Change between groups in baseline impedance value. Impedance baseline values will be assessed in two steady periods of 30 seconds at the beginning and at the end of consecutive time windows of 30 minutes, 60 minutes.
次要结局
- Microscopic esophagitis(3 weeks)
- Intercellular spaces(3 weeks)
- The expression of tight junctions(3 weeks)
- Esophageal permeability(3 weeks)
- ReQuest Questionnaire score(3 weeks)
- Esophageal acid exposure(3 weeks)
- Esophageal reflux episodes(3 weeks)
研究者
研究点 (2)
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