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.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
5
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
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