Analysis of the effects of GERDOFF tablets in patients with gastric reflux who do not respond to other drugs (alginates)

Not Applicable

Completed

• Conditions: Gastroesophageal reflux; Digestive System

• Registration Number: ISRCTN15143752
• Lead Sponsor: Sofar Spa

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32721918/ (added 31/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-20
• Study Start: 2017-12-19
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified