Status:
COMPLETED
Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor
Lead Sponsor:
SOFAR S.p.A.
Conditions:
Gastro-oesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. Thes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03793556
Start Date
May 5 2017
End Date
December 11 2018
Last Update
March 31 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
dr Alessandro Repici
Rozzano, MI, Italy, 20089