Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

SOFAR

Status: Completed

Conditions: Gastro Esophageal Reflux

Treatments: Device: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet; Device: Placebo 1100 mg, identically-looking melt in mouth tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04202692

PSC-DS MATRIX 19

Details and patient eligibility

About

This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs.

Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
• Male and female out-patients aged 18 to 80 years
• GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
• EGD endoscopy performed within 1 year before screening
• Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
• Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)

Exclusion criteria

• Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
• Histological evidence of Barrett's oesophagus > 1 cm in EGD endoscopy
• Peptic stricture in EGD endoscopy
• Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
• Known impaired kidney or liver function at screening
• Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
• Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) 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 not employing adequate contraceptive methods
• Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

GERDOff Plus

Experimental group

Description:

Hyaluronic acid + 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: Placebo 1100 mg, identically-looking melt in mouth tablet

Device: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet

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 1100 mg, identically-looking melt in mouth tablet

Device: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet