CONTINUOUS INTRAGASTRIC PH MONITORING IN THE EVALUATION OF EBROTIDINE, CIMETIDINE AND PLACEBO ON GASTRIC-ACIDITY IN HEALTHY-VOLUNTEERS

This study was conducted to determine the efficacy and tolerance of eb rotidine ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981 -43-9, FI-3542), a new H-2-receptor antagonist, on reducing gastric ac idity after a single 800 mg dose, compared with cimetidine 800 mg once daily and placebo by means of a continuous intragastric pH monitoring . A total of 30 healthy volunteers were allocated to receive in a doub le blind, parallel design the study medication. Clinical observations, physical examinations and visual analogue scales (VAS) were performed during the study to assess the tolerability of the three treatments. Ebrotidine and cimetidine caused a greater and longer-lasting gastric acid inhibition than placebo. With ebrotidine, significantly (p < 0.05 ) higher median pH values (and interquartile range, IQR) were reached in the post-administration (2.61, IQR 2.02-3.93), postprandial (3.38, IQR( 2.82-3.91) and nocturnal (2.83, IQR 1.69-3.77) periods than with placebo: 1.82 (IQR, 1.66-2.09), 2.81 (IQR, 2.02-3.28), and 1.89 (IQR, 1.44-2.13), respectively. Cimetidine showed significant differences co mpared to placebo in the post-administration (2.36, IQR 1.89-3.46) and nocturnal (2.46, IQR 1.88-4.33) periods. No statistical differences w ere observed between the active treatments. Ebrotidine caused a signif icantly higher percentage of time above pH 2.0 in the post-administrat ion and nocturnal periods compared to placebo (p < 0.05), and above pH 3.0 in the postadministration, postprandial and nocturnal periods. No serious adverse effects, or disturbances in the VAS or in the vital s igns were reported, and all medications were well tolerated. It is con cluded that a single dose of ebrotidine 800 mg is as effective as cime tidine 800 mg in reducing total and nocturnal intragastric acidity. Th e study also confirms the excellent safety profile of the new drug.