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

Phase 2

Completed

• Conditions: Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus
• Interventions: Drug: Nitazoxanide

• Registration Number: NCT01328925
• Lead Sponsor: Romark Laboratories L.C.

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 Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2011-03-29
• Status Verified: 2011-04
• Study First Submitted QC: 2011-04-01
• Last Update Submitted: 2011-04-01
• Study First Posted: 2011-04-05
• Last Update Posted: 2011-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age < 6 years.
• Patients with diarrhea (defined as 3 or more liquid stools per day).
• Stool positive for rotavirus by ELISA.

Exclusion Criteria

• Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
• Serious systemic disorders incompatible with the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitazoxanide Oral Suspension	Nitazoxanide	Nitazoxanide Oral Suspension 100 mg/5 ml
Placebo Oral Suspension	Nitazoxanide	Placebo Oral Suspension

Primary Outcome Measures

Name	Time	Method
Time from first dose to resolution of symptoms.	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.

Secondary Outcome Measures

Name	Time	Method
Time from first dose to virologic response	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	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	Up to 14 days
Frequency of intravenous rehydration required	Up to 14 days
Stool weight	Up to 14 days

Trial Locations

Locations (1)

Cairo University Children's Hospital; 🇪🇬 Cairo, Egypt