Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor
Status:
Completed
Trial end date:
2018-12-11
Target enrollment:
Participant gender:
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.