Back to resultsStudy of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Primary Purpose
Rotavirus Infection, Adenoviridae Infection, Norovirus Infection
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alinia (nitazoxanide)
Sponsored by
About this trial
This is an interventional treatment trial for Rotavirus Infection
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitazoxanide
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Time from first dose to resolution of symptoms.
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
Secondary Outcome Measures
Virologic response (negative ELISA) at day 7-10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00302640
Brief Title
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Official Title
Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Infection, Adenoviridae Infection, Norovirus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Alinia (nitazoxanide)
Primary Outcome Measure Information:
Title
Time from first dose to resolution of symptoms.
Description
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
Time Frame
P-0.0105
Secondary Outcome Measure Information:
Title
Virologic response (negative ELISA) at day 7-10.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Abu-Zekry, MD
Organizational Affiliation
Cairo University Children's Hospital, Cairo, Egypt
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16829296
Citation
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.
Results Reference
result
Learn more about this trial
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
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