RESUMEN
OBJECTIVE: To evaluate the effect of ilaprazole enteric tablets on intragastric pH in duodenal ulcer patients. METHODS: A randomized, double blind, positive controlled clinical trial was carried out. A total of forty-two patients with duodenal ulcer were randomized into low dose ilaprazole group (5 mg/d), medium dose ilaprazole group (10 mg/d), high dose ilaprazole group (20 mg/d) and omeprazole group (20 mg/d). An ambulatory 24 hour intragastric pH study was performed at the fifth treatment day. Fraction time pH above 3, 4 or 5, median values of 24 hour diurnal pH and 12 hour nocturnal pH, the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours were evaluated. RESULTS: There were no significant differences of fraction time pH above 3 or 4, median values of 24 hour diurnal pH and 12 hour nocturnal pH and the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours among all the groups with different doses of ilaprazole and the omeprazole group. The fraction time pH above 5 in medium and high dose ilaprazole groups were (87.96 + or - 12.29)% and (89.86 + or - 15.18)% respectively, which was higher than that in low dose ilaprazole group [(67.17 + or - 30.16)%] and omeprazole group [(76.14 + or - 16.75)%], P < 0.05. CONCLUSION: Ilaprazole has a strong effect on intragastric acid control with a dose dependent trend.