Itopride (Ganaton®) is a prokinetic with an antiemetic effect which a) promotes the peristalsis of the oesophagus, b) stimulates gastric motility, c) hastens gastric evacuation, d) improves gastroduodenal coordination, e) enhances peristaltic activity, f) shortens the passage through the small intestine. Objective: Evaluation of the effectivity of the preparation in patients with upper functional dyspepsia. Method: Baseline criteria: 1. Diagnosis of upper functional dyspepsia (according to common criteria), 2. duration at least 3 months, 3. age above 18 years, 4. informed consent. Baseline examination: usual physical examination, ECG (incl. QTc), sonographic examination of the abdomem, endoscopy of the upper digestive tract (incl. Hp), pregnancy test, red cell sedimentation rate, haemogram, so-called liver tests, urea, creatinine, potassium, sodium and chlorides in serum, prolactin. Check-ups: 14th–17th, 28th–31st, 56th–59th, 84th–87th day. Patients: 91 subjects, mean age 39 years (range 18–79 years), comprising 36 (39.6%) men, mean age 37 years (18–67 years) and 50 (60.4%) women mean age 41 years (18–79 years). From the investigation a total of 6 patients were eliminated, one on account of headache, which developed after 28 days and 5 patients did not attend the check-up examination. Results: After 56 days of treatment with itopride in the group of 91 patients a statistically significant improvement was recorded: pain in 88.4% (p < 0.001) , discomfort in 88.3% (p < 0.001), fullness in 82.8% (p < 0.001), nausea in 82.9% (p < 0.001), vomiting in 77.8% (p < 0.03), flatulence in 85.1% (p < 0.001), loss of appetite in 81.5% (p < 0.004) and early satiety in 85% (p < 0.001). During administration of the drug no significant prolongation of the QTc interval on the ECG was observed. None of the investigated laboratory values differed significantly from „normal values“ reported by different laboratories. As to side-effects one patient developed after 28 days headache and this patient was eliminated from the investigation. Conclusion: On evaluation by physicians general improvement was recorded after 56 days of itopride administration in 82 patients (i.e. 90.1%) with upper functional dyspesia. Therapy with itopride is a significant contribution to the treatment of functional gastric dyspepsia.

        Key words: upper functional dyspepsia –itopride – clinicaltests