The current proposal is a randomized, placebo-controlled, double-blinded crossover trial to determine the efficacy of cisapride, a gastrointestinal prokinetic, for the treatment of infantile colic. During the study period, parents keep crying time logs. Results of initial statistical analysis failed to show significant differences between cisapride (0.87 +/- 1.49 hours [mean ISD] and placebo (1.36 +/- 1.33 hours) or parental subjective rating. To show efficacy an extremely large sample size would be required suggesting minimal drug efficacy. During this study period 18 subjects were enrolled and the study terminated.
Showing the most recent 10 out of 502 publications