Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

Inclusion criteria

• 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

Exclusion criteria

• 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