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

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00302640
First received: March 13, 2006
Last updated: May 30, 2012
Last verified: May 2012

March 13, 2006
May 30, 2012
February 2005
Not Provided
Time from first dose to resolution of symptoms. [ Time Frame: P-0.0105 ] [ Designated as safety issue: No ]
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
Time from first dose to resolution of symptoms.
Complete list of historical versions of study NCT00302640 on ClinicalTrials.gov Archive Site
Virologic response (negative ELISA) at day 7-10.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Rotavirus Infection
  • Adenoviridae Infection
  • Norovirus Infection
Drug: Alinia (nitazoxanide)
  • Active Comparator: Nitazoxanide
    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
    Intervention: Drug: Alinia (nitazoxanide)
  • Placebo Comparator: Placebo
    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
    Intervention: Drug: Alinia (nitazoxanide)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2005
Not Provided

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.
Both
up to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00302640
RM02-3021
Not Provided
Not Provided
Romark Laboratories L.C.
Not Provided
Principal Investigator: Mona Abu-Zekry, MD Cairo University Children's Hospital, Cairo, Egypt
Romark Laboratories L.C.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP