The variability in oro-cecal transit time assessed using a bean-based test meal and its use in the study of the effect of metoclopramide and BRL 24924 on transit time.

The inter and intra subject variation in the oro-cecal transit time assessed using the bean/breath hydrogen method was studied and analyzed to allow estimation of the number of patients/subjects required to show a drug-induced difference for given levels of statistical significance and power. Thus at the conventional 5% level of significance and for a test with 90% power, a dozen subjects should be sufficient to show a drug-induced change which is 25% or greater. Two crossover studies are described using 20 mg metoclopramide and 2 mg BRL 24924, orally, against placebo to investigate their action on oro-cecal transit time. Metoclopramide, 20 mg, produced a 45% reduction in the transit time compared with placebo. BRL 24924, 2 mg, in a similar study showed a 71% reduction.