Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 13, 2006
Actual (reported)March 14, 2006
Actual (reported)Time from first dose to resolution of symptoms.
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
P-0.0105
Virologic response (negative ELISA) at day 7-10.
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
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
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. doi: 10.1016/S0140-6736(06)68852-1.
Mona Abu-Zekry, MD
Cairo University Children's Hospital, Cairo, Egypt
50 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2006
First Posted
March 14, 2006
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
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Study Completion
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
May 31, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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