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
Conditions
Interventions
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
Concentra
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1 History of erosive esophagitis and / or Barrett's Esophagus 2. Inflammatory bowel diseases 3. Clinical signs of malabsorption 4. Previous surgery to the gastrointestinal tract is not included cholecystectomy and appendectomy 5. Connective tissue diseases (scleroderma, SLE, RA) 6. Concomitant renal, hepatic, cardiac (angina and AMI) 7. Chronic concomitant therapy with NSAIDs, aspirin doses of antiplatelet drugs that interact with esomeprazole (eg clopidogrel) 8. Hypersensitivity / allergic to esomeprazole or its excipients 9. Pregnancy or breast-feeding during 10. Previous diagnosis of Post Nasal Drip Cough-related syndrome (PNDS) or bronchial asthma 11. Neurological diseases (Alzheimer's or Parkinson's disease) or psychiatric (reducing the capacity to understand purpose, possible benefits and potential adverse events resulting from participation in the study, and that could undermine the collaboration involving the study as per protocol), in particular the presence of noise psychotic mental underway. 12. chronic alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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.;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;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactUO gastroenterologia
Universita' Campus Bio-Medico di Roma
Outcome results
None listed