Clinical Trial: Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children

Brief Summary: The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

Detailed Summary:
Sponsor: Romark Laboratories L.C.

Current Primary Outcome: Time from first dose to resolution of symptoms [ Time Frame: Up to 17 days ]

Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged 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 72 hours to be considered valid.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Romark Laboratories L.C.

Dates:
Date Received: March 28, 2011
Date Started: March 2005
Date Completion:
Last Updated: March 29, 2011
Last Verified: March 2011