Effects of fedotozine on gastric emptying and upper gastrointestinal symptoms in diabetic gastroparesis

Background: Delayed gastric emptying and upper gastrointestinal symptoms oc cur frequently in patients with diabetes mellitus. Aim: To evaluate the effects of fedotozine on gastric emptying and gastroin testinal symptoms in diabetic gastroparesis. Methods: Thirty-one diabetic patients (20 type 1, 11 type 2) with gastropar esis were randomized to receive fedotozine (30 mg as the tartrate) or place bo t.d.s. Measurements of gastric emptying (100 g ground beef labelled with 20 MBq Tc-99m-sulphur colloid chicken liver and 150 mL 10% dextrose labell ed with 10 MBq In-113m-DTPA) and gastrointestinal symptoms were performed b efore and after 12-16 days of treatment. Data are the mean +/- s.d. Results: Of the 31 patients enrolled, two were excluded from analysis. Data from the remaining 29 patients (18 type 1, 11 type 2; 22 female, seven mal e), aged 42.7 +/- 11.1 years (of whom 14 were randomized to fedotozine and 15 to placebo), were analysed. Fedotozine had no effect on either gastric e mptying (solid retention at 100 min; fedotozine: baseline, 84 +/- 15%; trea tment, 73 +/- 23% vs. placebo: baseline, 83 +/- 10%; treatment, 70 +/- 20%) or liquid 50% emptying time (fedotozine: baseline, 59 +/- 32 min; treatmen t, 58 +/- 38 min vs. placebo: baseline, 44 +/- 9 min; treatment, 43 +/- 21 min) or gastrointestinal symptoms (fedotozine: baseline, 4.4 +/- 2.9; treat ment, 4.1 +/- 3.9 vs. placebo: baseline, 4.9 +/- 4.2; treatment, 4.8 +/- 3. 9). Conclusions: Fedotozine has no effect on gastric emptying in patients with diabetic gastroparesis.