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
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 IdentifierNCT04202692
SponsorSOFAR S.p.A.
Last Modified on15 May 2022

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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