Efficacy of a medical product containing sorbitol, simethicone and citrate potassium, in comparison with domperidone in patients affected by disfunctional dyspepsia: randomized monocentric cross-over controlled clinical trial. - ND

Conditions: dysfunctional dyspepsia
MedDRA version: 9.1Level: LLTClassification code 10064536Term: Functional dyspepsia

Registration Number: EUCTR2008-005747-42-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

We include in the trial 20 patients older than 18 years old, affected by functional dyspepsia (diagnosis in according to Rome II criteria), in which an organic gastroenteric disease had already been excluded by laboratory tests and endoscopy. All patients have to stop drugs as sucralfate, misoprostole, anti-acid agents and procinetics almost a week before starting the trial.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

We exclude from the trial patients with one of the following features: pregnancy, gastroenterological diseases (like oesophagitis, Barrett?s dysplasia, erosive gastritis, peptic disease, Helicobacter pylori infection, gastroesophageal reflux disease, gastrointestinal dismotility, irritable bowel sindrome), severe comorbilities (cardiopathies, pulmonary diseases, electrolytic alterations, autoimmune diseases, tumors, diabetes mellitus), previous abdominal surgery (except appendicectomy and cholecistectomy), contemporary therapy with drugs able to modify gastroenteric function (NSAD, steroids, aspirine, macrolides, azoles, methotrexate, bifosfonates, benzodiazepine, antidepressant drugs), history in the last six months of stressant events able to reduce psychophysical welfare (death, divorce, lost of the job).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: nd;Primary end point(s): nd;Main Objective: Primary aim of the trial is to compare therapeutic properties of the medical product containing sorbitol, simethicone and citrate potassium with domperidone in patients affected by dysfunctional dyspepsia. We evaluate the improvement both of symptoms and of quality of life.

Secondary Outcome Measures