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

Background: Delayed gastric emptying and upper gastrointestinal symptoms occur frequently in patients with diabetes mellitus. Aim: To evaluate the effects of fedotozine on gastric emptying and gastrointestinal symptoms in diabetic gastroparesis. Methods: Thirty‐one diabetic patients (20 type 1, 11 type 2) with gastroparesis were randomized to receive fedotozine (30 mg as the tartrate) or placebo t.d.s. Measurements of gastric emptying (100 g ground beef labelled with 20 MBq 99m Tc‐sulphur colloid chicken liver and 150 mL 10% dextrose labelled with 10 MBq 113m In‐DTPA) and gastrointestinal symptoms were performed before 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 male), 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 emptying (solid retention at 100 min; fedotozine: baseline, 84 ± 15%; treatment, 73 ± 23% vs. placebo: baseline, 83 ± 10%; treatment, 70 ± 20%) or liquid 50% emptying time (fedotozine: baseline, 59 ± 32 min; treatment, 58 ± 38 min vs. placebo: baseline, 44 ± 9 min; treatment, 43 ± 21 min) or gastrointestinal symptoms (fedotozine: baseline, 4.4 ± 2.9; treatment, 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.