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

SOFAR

Status: Completed

Conditions: Gastro Esophageal Reflux

Treatments: Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03883074

PSC-DS TRIGERD 18

Details and patient eligibility

About

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

GERDOff® Plus

Experimental group

Description:

hyaluronic acid with chondroitin + sulphate + magnesium trisilicate Melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.

Treatment:

Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate

Placebo

Placebo Comparator group

Description:

Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.

Treatment:

Device: Placebo