Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.

Inclusion Criteria:

• Age < 6 years.
• Patients with diarrhea (defined as 3 or more liquid stools per day).
• Stool positive for rotavirus by ELISA.

Exclusion Criteria:

• Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
• Serious systemic disorders incompatible with the study.