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

STATUS

Recruiting
End date

Jun 30, 2023
participants needed

40
sponsor

SOFAR S.p.A.

Updated on 15 May 2022

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endoscopy

Summary

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

Details

Condition	Gastro Esophageal Reflux
Treatment	Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet, Placebo 1100 mg, identically-looking melt in mouth tablet
Clinical Study Identifier	NCT04202692
Sponsor	SOFAR S.p.A.
Last Modified on	15 May 2022

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Eligibility		Yes	No	Not Sure
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

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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