dysfunctional dyspepsia MedDRA version: 9.1 Level: LLT Classification code 10064536 Term: Functional dyspepsia
Conditions
Interventions
Trade Name: PERIDON
Pharmaceutical Form: Effervescent granules
INN or Proposed INN: Domperidone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed