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...
Date First Received: March 13, 2006
Last Updated: November 27, 2006
Verified by: Romark Laboratories L.C., March 2006
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: February 2005
Overall Status: Completed
Estimated Enrollment: 50
Brief Summary
Official Title: “Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Alinia (nitazoxanide)
Outcome Measures for this Clinical Trial
Primary Measures
- Time from first dose to resolution of symptoms.
Secondary Measures
- Virologic response (negative ELISA) at day 7-10.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 11 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Romark Laboratories L.C.
Overall Clinical Trial Officials and Contacts
Mona Abu-Zekry, MD Principal Investigator Cairo University Children's Hospital, Cairo, Egypt
Related Publications
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00302640
Study ID Number: RM02-3021
ClinicalTrials.gov Identifier: NCT00302640
Health Authority: Egypt: Ministry of Health and Population
Clinical Trials Authorship and Review
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