The effects of 75 mg HOE 760, a novel H2-receptor antagonist, on daytime peptone-stimulated and nocturnal gastric acid output in healthy volunteers.

The effects of HOE 760, a highly specific H2-receptor antagonist, on daytime peptone-stimulated and nocturnal gastric acid output were studied (randomized, double-blind crossover) in 10 healthy men. Acid output was monitored at lunch (1200 h to 1400 h) and dinnertime (1800 h to 2000 h) by continuous automatic intragastric titration; from midnight to 0600 h, output was measured by titration of manually aspirated gastric contents. After a 75-mg oral dose (capsule containing HOE 760 granules) at 0800 h peptone-stimulated acid output decreased for at least 12 h. Compared with placebo, significant reductions (p less than 0.05) of 86% and 32% were observed 4-6 h and 10-12 h after drug administration. After another dose of 75 mg at 2100 h nocturnal acid output was significantly reduced (p less than 0.05) by 88%; gastric pH was increased by about 2 units throughout the night. HOE 760 was well tolerated. No adverse reactions occurred; no clinically relevant changes were noted in haematologic, biochemical, urinary, or electrocardiographic variables.

RCT Entities:   Population Interventions Outcomes