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

Phase 2

Completed

• Conditions: Norovirus Infection; Rotavirus Infection; Adenoviridae Infection
• Interventions: Drug: Alinia (nitazoxanide)

• Registration Number: NCT00302640
• Lead Sponsor: Romark Laboratories L.C.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study Completion: 2005-09
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitazoxanide	Alinia (nitazoxanide)	7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days
Placebo	Alinia (nitazoxanide)	7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days

Primary Outcome Measures

Name	Time	Method
Time from first dose to resolution of symptoms.	P-0.0105	Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group

Secondary Outcome Measures

Name	Time	Method
Virologic response (negative ELISA) at day 7-10.