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Completed

NCT Number: NCT00302640

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

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.

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Key information

Conditions

Rotavirus Infection Adenoviridae Infection Adenoviridae Infections Caliciviridae Infections DNA Virus Infections Infections Norovirus Infection RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alinia (nitazoxanide)

Drug

Primary outcomes

  1. Time from first dose to resolution of symptoms.

    Time frame: P-0.0105

    Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group

Secondary outcomes

  1. Virologic response (negative ELISA) at day 7-10.

Sponsors and collaborators

Lead sponsor

Romark Laboratories L.C.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Mar 14, 2006
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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