ISRCTN15143752Completed未知
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.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Sofar Spa
- Enrollment
- 40
Study Overview
Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/32721918/ (added 31/07/2020)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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