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

Launched by SOFAR S.P.A. · Mar 19, 2019

Keywords

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Gender

ALL

Eligibility criteria

• 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