Overview

Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Romark Laboratories L.C.
Treatments:
Nitazoxanide
Criteria
Inclusion Criteria:

- Age <12 years.

- Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid
consistency, the number and consistency of stools being unusual for that person).

- Stool positive for adenovirus, norovirus or rotavirus by ELISA.

Exclusion Criteria:

- Females who are pregnant, suspected of being pregnant or breastfeeding.

- Other identified causes of diarrhea at screening.

- Serious systemic disorders incompatible with the study.