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

This study has been completed.

First Received: March 13, 2006 Last Updated: November 27, 2006 History of Changes

Sponsored by:	Romark Laboratories L.C.
Information provided by:	Romark Laboratories L.C.
ClinicalTrials.gov Identifier:	NCT00302640

Purpose

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.

Condition	Intervention	Phase
Rotavirus Infection Adenoviridae Infection Norovirus Infection	Drug: Alinia (nitazoxanide)	Phase II Phase III

MedlinePlus related topics: Diarrhea Rotavirus Infections

Drug Information available for: Nitazoxanide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:

Time from first dose to resolution of symptoms.

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	February 2005
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	up to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302640

Sponsors and Collaborators

Romark Laboratories L.C.

Investigators

Principal Investigator:

Mona Abu-Zekry, MD

Cairo University Children's Hospital, Cairo, Egypt

More Information

Publications:

Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9.

Study ID Numbers:	RM02-3021
Study First Received:	March 13, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00302640 History of Changes
Health Authority:	Egypt: Ministry of Health and Population

Study placed in the following topic categories:

Virus Diseases
Diarrhea
Rotavirus Infections

Adenoviridae Infections
DNA Virus Infections
Nitazoxanide

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Rotavirus Infections
Adenoviridae Infections
Reoviridae Infections
Infection

Pharmacologic Actions
Virus Diseases
Antiparasitic Agents
Therapeutic Uses
DNA Virus Infections
Nitazoxanide

ClinicalTrials.gov processed this record on May 07, 2009