Overview

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.