[Efficacy and tolerance of cinitapride on the disturbances of gastrointestinal transit].

In order to evaluate the efficacy and tolerance of cinitapride, 103 patients with gastrointestinal disorders were admitted to a randomized, parallel, double blind trial for treatment with cinitapride, metoclopramide or placebo. Cinitapride was significantly more effective than metoclopramide in restoring normal defecation rates in constipated patients after 7 and 14 days of treatment (p = 0.036 and p = 0.008) and significantly more effective than placebo in restoring normal consistency of compact stools after 7 and 14 days of treatment (p = 0.006 and p = 0.051). Cinitrapide also proved to be significantly more effective than metoclopramide in curing or improving post-prandial epigastric distention (p = 0.031), post-prandial epigastric fullness (p = 0.037) and abdominal pain (p = 0.002) after 7 and 14 days of treatment. After treatment with cinitapride, dyspeptic symptoms disappeared or improved in 56-82% of patients. The efficacy rates in controlling gastrointestinal transit disorders, according to the investigators, were 64% for cinitapride, 28% for metoclopramide (p = 0.004) and 39% for placebo (p = 0.031) and, according to the patients, 55% for cinitapride, 25% for metoclopramide (p = 0.014) and 39% for placebo, 44% of the patients treated with cinitapride, 51% of the patients treated with metoclopramide and 26% of the patients treated with placebo reported and adverse reaction, with statistically significant differences between metoclopramide and placebo (p = 0.031). The tolerance rates, according to the investigators, were 82% for cinitapride, 64% for metoclopramide and 94% for placebo (placebo vs. metoclopramide, p = 0.001) and, according to the patients, 72% for cinitapride, 51% for metoclopramide and 89% for placebo (placebo vs. metoclopramide, p = 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)