Gastro-oesophageal Reflux Disease Clinical Trial
Official title:
Evaluation of the Effects of GERDOFF in Combination With a 6-week Therapy Based on Proton Pump Inhibitors Versus Proton Pump Inhibitors Alone on GERD-high Symptoms in Patients With Primary Diagnosis of Gastroesophageal Reflux Disease.
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.
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. These disorders may represent extra-esophageal manifestations of
gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been
proved as useful to improve patients' quality of life.
The aim of the present study was to evaluate, in first diagnosed patients presenting with
upper symptoms associated with GERD, the effect of a 6-week treatment with a combination
based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with
PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated
with the combination of the two products, the reduction in symptoms frequency by means of a
Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index
(RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients
included in the two groups were then classified as responders or non-responders. Responder
patients were defined as those patients that, at the 6th week of treatment, reached a RSI
score decreased for at least 50% compared to baseline and an absolute value < 13.
Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was
evaluated after a period of follow-up lasting 12 weeks, which could be entered only by
responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up
period were randomised to receive Gerdoff® or no treatment (control group). Safety data were
also evaluated in the group of patients that continued in the follow-up period.
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