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 ]

Resolution of all gastrointestinal symptoms associated with viral diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 48 hours to be considered valid.


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