Clinical Trial: Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Brief 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.
Detailed Summary:
Sponsor: Romark Laboratories L.C.
Current Primary Outcome: Time from first dose to resolution of symptoms. [ Time Frame: Up to 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time from first dose to virologic response [ Time Frame: Up to 14 days ]Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days.
- Time from first dose to hospital discharge [ Time Frame: Up to 14 days ]For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.
- Volume of oral rehydration solutions consumed [ Time Frame: Up to 14 days ]
- Frequency of intravenous rehydration required [ Time Frame: Up to 14 days ]
- Stool weight [ Time Frame: Up to 14 days ]
Original Secondary Outcome: Same as current
Information By: Romark Laboratories L.C.
Dates:
Date Received: March 29, 2011
Date Started: December 2005
Date Completion:
Last Updated: April 1, 2011
Last Verified: April 2011