NCT01328925

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.

Conditions

• Rotavirus Infection
• Viral Gastroenteritis Due to Rotavirus

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide Oral Suspension dose based on age: Age \<12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2011-04-05
• Last updated: 2011-04-05

Locations

1 site across 1 country: Egypt