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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

Criteria

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.