Dose-finding clinical assay of triletide in gastric and duodenal ulceration

Three groups of 15 patients with endoscopically confirmed active gastric or duodenal ulcer were treated over a period of 8 weeks with daily doses of 1, 1.5 or 2 g triletide, an anti-ulcer agent which acts by enhancing the mucosal defence capacity. Intensity of epigastric pain and of heartburn and weekly consumption of standard antacid tablets, as well as possible accessory symptoms, were recorded every other week, endoscopy was repeated at the end of treatment and routine haematology and haematochemistry performed before and after treatment. The proportion of patients found to be endoscopically healed was significantly correlated to the log of the dose used, giving an ED50, under the test conditions, of 1.2 g/day (86.7% healed at 2 g/day). The improvement in each assessed symptom was significantly correlated with time according to an exponential regression. The computed exponent indicated that each higher dose resulted in a significantly faster regression of symptoms than each lower dose (mean time to decrease symptoms by 50%; 4.3 weeks at 2 g/day; 7.4 weeks at 1.5 g/day; and 20.8 weeks at 1 g/day). Moreover, two-ways analysis of variance indicated a significant dose-time interaction (p less than 0.01); thus, the improvement provided at any given time was more than proportional to the used dose. Tolerance was good at all three dose levels and no variations in haematology and haematochemistry could be detected. It is concluded that triletide, at a dose of between 1.5 and 2 g/day according to the patient's condition, appears to be an effective and well-tolerated means of promoting healing and controlling symptoms in peptic ulcer patients.