Aim: To assess the usefulness of early evening administration of roxatidine 150 mg as an alternative to the traditional bedtime regimen.
Methods: Twenty-four patients with healed duodenal ulcer were dosed according to a balanced incomplete-block design, with two of the following regimens: placebo, roxatidine 150 mg at 07.30 h (early evening) or roxatidine 150 mg at 22.00 h (bedtime). Twenty-four-hour intragastric pH-metry was started at 18.00 h on the first day of dosing. Median pH was determined for the 24-h period, and for the following time intervals: 20.00-00.00 h, 00.00-08.00 h and 08.00-18.00 h. Percentage time in the 24-h period with pH greater than 4.0 was also calculated.
Results: The two roxatidine regimens proved significantly superior to the placebo, decreasing 24-h acidity for all the time intervals, except the 20.00-00.00 h period, when mean intragastric pH with the early evening regimen (4.5 +/- 1.1) proved significantly higher than after placebo (2.2 +/- 1.0) or when roxatidine was taken at bedtime (2.4 +/- 1.1).
Conclusion: Early evening administration of roxatidine may afford satisfactory control of 24-h acidity, offering a useful alternative to conventional bedtime administration.