Cisapride in the control of symptoms in infants with gastroesophageal reflux: A randomized, double-blind, placebo-controlled trial

J Pediatr. 1999 Mar;134(3):287-92. doi: 10.1016/s0022-3476(99)70451-8.


Objective: To evaluate the efficacy of cisapride in the treatment of uncomplicated gastroesophageal reflux in children younger than 36 months of age.

Study design: A total of 95 patients satisfied the entry criteria and were randomly assigned to double-blind treatment with either cisapride (n = 50), 0.2 mg/kg 4 times daily, or placebo (n = 45) for 2 weeks. At the end of the 2-week treatment period, symptom diary and parental evaluation with repeat 24-hour pH study were performed.

Results: Sixty-eight patients completed the trial (38 in the cisapride group and 30 in the placebo group). There were no significant differences in the symptoms of crying, vomiting, or gagging; the overall symptom intensity score; or parental global evaluations. There was a significant difference (P <.03) in the percent time pH <4, the number of reflux episodes lasting more than 5 minutes, and the duration of the longest episode. No significant difference was demonstrated for the number of episodes with pH <4 or the reflux score.

Conclusions: Cisapride was no better than placebo for relief of symptoms in children with uncomplicated gastroesophageal reflux. A beneficial effect was demonstrated in the cisapride group in relation to the measured parameters for esophageal acid exposure time.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Australia
  • Chi-Square Distribution
  • Cisapride / adverse effects
  • Cisapride / therapeutic use*
  • Double-Blind Method
  • Esophagus / physiopathology
  • Female
  • Gastroesophageal Reflux / diagnosis
  • Gastroesophageal Reflux / drug therapy*
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Hydrogen-Ion Concentration
  • Infant
  • Male
  • Placebos
  • Statistics, Nonparametric
  • Treatment Failure


  • Gastrointestinal Agents
  • Placebos
  • Cisapride