Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

• Status: Completed
• Trial end date: 2018-12-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOFAR S.p.A.
• Treatments: Omeprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years;

2. 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;

3. Presence of extra-oesophageal symptoms associated with GERD;

4. RSI score ≥ 20;

5. 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;

6. Cooperative patients, able to understand and adhere to the study procedures;

7. Patient able to freely give their written informed consent to study participation;

8. Patients that freely gave the consent to management of personal data related to the study.

Exclusion Criteria:

1. Known infective oesophagitis or oesophagitis due to acid or alkaline substances;

2. Acute or chronic rhinosinusitis;

3. Chronic bronchitis;

4. Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;

5. Ongoing neoplasias;

6. Uncontrolled diabetes;

7. Patients with impaired liver function;

8. Patients with rare hereditary problems of galactose intolerance;

9. 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®);

10. Patients with deficiency of Lapp lactase;

11. Patients with syndrome of glu-gal malabsorption;

12. Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;

13. Patients already in treatment with PPIs or similar products;

14. Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);

15. Abuse of drug or alcohol;

16. Inability of the subject to adequately express his/her disturbances;

17. Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;

18. Lactating patients.