A prospective, multicenter, open-label, patients with non-erosive gastroesophageal reflux disease (NERD) non-responders to therapy with PPIs

INTERVENTION: Trade Name: NEXIUM*30CPR GASTR 40MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: ESOMEPRAZOLE CAS Number: 119141‐88‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ CONDITION: non‐erosive gastroesophageal reflux disease and apparently resistant to medical therapy with proton pump inhibitors ; MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: a) the prospective evaluation of the prevalence data ‐ based on proper compliance, timing, type and dose of PPI ‐ of NERD patients with typical symptoms (vs. atypical and extra‐esophageal) resistant or poorly responsive to treatment with esomeprazole 40mg for 8 weeks / day Primary end point(s): a) the prospective evaluation of the prevalence data ‐ based on proper compliance, timing, type and dose of PPI ‐ of NERD patients with typical symptoms (vs. atypical and extra‐esophageal) resistant or poorly responsive to treatment with esomeprazole 40mg for 8 weeks / day Secondary Objective: ‐evaluation of the prevalence in the group of patients with absent or poor response to PPIs, of patients with FH;; ‐evaluation of the characteristics of gastroesophageal reflux, in physical, chemical and dynamic (with pH‐impedance), in patients with known resistance to NERD and PPI in patients with functional heartburn. Timepoint(s) of evaluation of this end point: 8 weeks SECONDARY OUTCOME: Secondary end point(s): ‐la valutazione della prevalenza, nel gruppo di pazienti con assente o scarsa risposta agli IPP, di pazienti con FH; ; ‐la valutazione delle caratteristiche del reflusso gastroesofageo, in termini fisico‐chimici e dinamici (con pH‐impedenzometria), nei pazienti NERD con accertata resistenza ai IPP e nei pazienti con pirosi funzionale. Timepoint(s) of evaluation of this end point: 10 weeks INCLUSION CRITERIA: 1. Men and women aged between 18 and 70 years with: a. Heartburn (GERD symptom) or not associated with atypical symptoms (chest pain, globe, hoarseness, cough, throat tickle "throat clearing"), though the latter correlated to the meal and / or supine position • Intensity of symptoms greater than or equal to the score of 3 on a numeric scale (responses 1‐3) • Presence of symptoms at least 2 times a week, and at least 6 months (with or without previous therapy) (responses 1‐3) 2. Endoscopy negative for the presence of erosions in the esophagus, performed over the past two years, drug washout (H2‐antagonists and PPIs) for at least 4 weeks. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200