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

Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302640

Enrollment

Registered

2006-03-14

Start date

2005-02-28

Completion date

2005-09-30

Last updated

2012-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoviridae Infection, Norovirus Infection, Rotavirus Infection

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.

Interventions

DRUGAlinia (nitazoxanide)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Virologic response (negative ELISA) at day 7-10.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026