Exploratory, post-market, open-label clinical investigation to evaluate the effect of the medical device, GERDOFF® melt-in-mouth tablets, in patients with GERD and with reduced effect or ineffectiveness of alginates treatment.

Sofar Spa0 个研究点目标入组 40 人开始时间: 2017年12月19日最近更新: 2020年8月10日

适应症

试验速览

•1. Aged =18 years
•2. Having symptoms associated to diagnosis of GERD, performed on clinical basis with the presence of following symptoms
•2.1. Heartburn and/or regurgitation, diurnal and/or nocturnal, of moderate intensity, at least twice a week, for at least two weeks, disturbing the patient during normal activities and/or in the recovery of night-time sleep, whether or not accompanied by other symptoms
•3. Having a medical report of EGDS performed within 3 months prior to the study start, excluding other diseases in the upperpart of the digestive system (e.g. erosion/ulcer gastric or duodenal)
•4. Responding to PPI treatment during the 6 months prior to the study start
•5. Having a disease not controlled by alginate treatment, taken on the basis of the dosage recommendations given in the leaflet for at least 2 weeks prior to study initiation
•6. Being able to understand and comply with the study procedures
•7. Being able to provide a written informed consent to participate into the study
•8. Being able to provide a consent to the processing of personal data related to the study

•1. Known esophagitis caused by infection or by acid or alkaline substances
•2. Treatment for eradication of Helicobacter Pylori (HP) in the 30 days prior to informed consent signature
•3. Concomitant PPI therapy, if not already in use in the 2 weeks prior to V0
•4. Expected alginates intake during the study
•5. Patients, who planned to use during the course of the study anti-acids, prokinetics, anti-H2, or other pharmaceutical products and/or over-the-counter products and/or medical devices indicated for the treatment of GERD, will not be included
•6. History of Zollinger-Ellison syndrome, hiatal hernia and Barrett's oesophagus
•7. Known diabetes
•8. Inability of the patient to adequately describe his/ her disorders
•9. Unauthorized consent to the processing of personal data
•10. Planned or known pregnancy
•11. Breastfeeding
•12. Participation in other clinical trials/investigations with drugs or experimental products within 3 months prior to enrolment

发起方