Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
Phase 2
Completed
- Conditions
- Norovirus InfectionRotavirus InfectionAdenoviridae Infection
- Interventions
- Registration Number
- NCT00302640
- Lead Sponsor
- Romark Laboratories L.C.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nitazoxanide Alinia (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 Placebo Alinia (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
- Primary Outcome Measures
Name Time Method Time from first dose to resolution of symptoms. P-0.0105 Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
- Secondary Outcome Measures
Name Time Method Virologic response (negative ELISA) at day 7-10.