Effect of an effervescent citrate-cimetidine combination on intragastric pH in healthy subjects. A randomized, placebo-controlled three-period cross-over design.
Twelve healthy male volunteers participated in a randomized placebo-controlled, three-period cross-over study to assess the effect of a new effervescent citrate-cimetidine combination (200 mg cimetidine/tablet) (C) on intragastric pH in comparison with a liquid aluminium-magnesium hydroxide antacid (A) and placebo (P). The intragastric pH values were determined by an Ingold combined glass electrode and recorded by a "pH 60" portable unit. Each pH-metry lasted 5 hours and was performed on three separate occasions at one-week intervals. Each treatment was orally administrated at 09.00 h, following a 1-hour baseline intragastric pH recording. The effect of C was measurable almost immediately after drug intake with a median pH between 5-6.5 within 3 minutes, lasting for a mean of 110 minutes and median pH greater than 4 for at least 4 hours. The rise of gastric pH with C was higher (P less than 0.01) and longer (P less than 0.01) than that of A: median pH between 3.5 and 4.5 for 10 to 35 minutes, pH above the placebo curve for 140 minutes and above pH 3 for 50 minutes. In terms of percentage of time at or above each pH level, the differences between the three treatment groups were significantly in favor of C compared to A and A compared to P.
Ducrotté
P
P
Groupe de Biochimie et de Physiopathologie Digestive et Nutritionnelle, Hôpital Charles-Nicolle, Rouen.
Weber
J
J
Colin
R
R
Denis
P
P
D000328:Adult; D000863:Antacids / Q000494:pharmacology; D002927:Cimetidine / Q000494:pharmacology*; D002951:Citrates / Q000494:pharmacology*; D004311:Double-Blind Method; D004338:Drug Combinations; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D005750:Gastric Juice / Q000187:drug effects*; D006801:Humans; D008297:Male; D010919:Placebos; D012016:Reference Values; D013268:Stimulation, Chemical; D013997:Time Factors
D000863:Antacids; D002951:Citrates; D004338:Drug Combinations; D010919:Placebos; D002927:Cimetidine