N/A N=71 Randomized Treatment

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

Gastro-oesophageal Reflux Disease

Bottom Line

View on ClinicalTrials.gov: NCT03793556 ↗

Enrolled (actual)

Serious AEs

1.4%

Results posted

Mar 2020

Primary outcome: Primary: Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire — -16.2; -13.7 Score on a scale — p=0.276

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GERDOFF® + Omeprazole (Device); Omeprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SOFAR S.p.A.
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire	-16.2; -13.7	0.276
SECONDARY Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed	24.2; 26.0; 15.3; 19.6; 12.9; 15.3	0.0157 sig
SECONDARY Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4	3.2; 2.8; 1.1; 1.6	—
SECONDARY Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance	3.4; 3.6; 1.4; 1.8	—
SECONDARY Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4	2.7; 2.8; 1.4; 1.9	—
SECONDARY Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4	1.9; 1.9; 0.4; 0.6	—
SECONDARY Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying	2.5; 3.3; 0.7; 1.7	—
SECONDARY Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4	1.5; 1.9; 0.5; 0.6	—
SECONDARY Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4	2.5; 3.7; 0.8; 1.5	—
SECONDARY Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4	3.0; 2.6; 0.8; 1.6	—
SECONDARY Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4	3.4; 3.5; 0.8; 3.5	—
SECONDARY Number of Responders V4	23; 20; 8; 16	0.0496 sig
SECONDARY Number of Responders V6	9; 7; 0; 1	—
SECONDARY Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4	19.0; 21; 7.4; 11.6	0.0065 sig
SECONDARY Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire	1; 4; 7; 2; 6; 9	—
SECONDARY Use of Rescue Medication (Omeprazole) During the Treatment	24; 28; 11; 8	—
SECONDARY Use of Rescue Medication (Omeprazole) During the Follow-up	7; 5; 2; 3	—
SECONDARY Use of Rescue Medication (Other Than Omeprazole) During Treatment	0; 4; 31; 32	—
SECONDARY Patients'Satisfaction	1; 0; 3; 1; 1; 7	—

Summary

The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms. The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.

Eligibility Criteria

Inclusion Criteria

Male or female subjects aged ≥ 18 years;
First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
Presence of extra-oesophageal symptoms associated with GERD;
RSI score ≥ 20;
Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
Cooperative patients, able to understand and adhere to the study procedures;
Patient able to freely give their written informed consent to study participation;
Patients that freely gave the consent to management of personal data related to the study.

Exclusion Criteria

Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
Acute or chronic rhinosinusitis;
Chronic bronchitis;
Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
Ongoing neoplasias;
Uncontrolled diabetes;
Patients with impaired liver function;
Patients with rare hereditary problems of galactose intolerance;
Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
Patients with deficiency of Lapp lactase;
Patients with syndrome of glu-gal malabsorption;
Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
Patients already in treatment with PPIs or similar products;
Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
Abuse of drug or alcohol;
Inability of the subject to adequately express his/her disturbances;
Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;
Lactating patients.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03793556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.