Gastroesophageal reflux Digestive System Gastroesophageal reflux
Conditions
Interventions
All patients are trained to take 4 melt-in -mouth tablets containing high molecular weight hyaluronic acid, aluminum hydroxide, and chondroitin sulphate (GERDOFF® 1100 mg
SOFAR S.p.A., Trezzano Rosa, Milan, Italy) after meals and before bedtime, for 14 days.
Participants are followed up to see if there is a reduction in the number of heartburn episode
Sponsors
Sofar Spa
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the number of heartburn episodes per week is measured using patient diaries at baseline, day 7 and day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of GERD- related symptoms are measured using patient diaries and the GIS Gerd impact scale questionnaire at baseline, day 7 and 14 2. Patient satisfaction is measured using GIS Gerd impact scale questionnaire at baseline, day 7 and day 14 3. Number of days without symptoms are measured using patient diaries at baseline, day 7 and day 14 4. Patient’s compliance to the therapy is measured using patient diaries at baseline, day 7 and day 14 | — |
Countries
Italy
Outcome results
None listed