MANTEINANCE TREATMENT IN NERD PATIENT. A COMPARATIVE RANDOMIZED OPEN STUDY BETWEEN ALGINATE AND MAGALDRATE. - ND

Conditions: Gastroesophageal reflux
MedDRA version: 9.1Level: LLTClassification code 10038263Term: Reflux oesophagitis

Registration Number: EUCTR2007-002934-12-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

age 18-75 years Gastroesophageal reflux (GOR) Negative endoscopy damage of esophagus and stomach
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Concomitant PPI treatment Pregnancy Systemic disease like diabete liver injury or renal failure Zollinger ellison syndrome Treatement with NSAIDS and anticoagulants Positivity to helicobacter pylori

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: this study was aimed at comparing the efficacy and safety of alginate, which acts with a physical antireflux mechanism, and magaldrate anhydrous, chosen as a representative antacid because of its wide use over decades in the treatment of GOR in symptomatic patients.;Secondary Objective: None declared;Primary end point(s): The primary efficacy variable will be the total sum of scores for heartburn and acid regurgitation over the 4 weeks treatment period expressed as (a) the symptom intensity difference (SID), i.e., the difference obtained by subtracting the patient's sum of symptom score intensity (SSSI) at each time point from the patient's baseline sum of symptom score; (b) the sum of the symptom intensity difference (SSID), i.e., the baseline-adjusted sum of the SID scores over time, expressed as the area under the time-effect curve for the treatment period (4 weeks).

Secondary Outcome Measures