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

Romark Laboratories

Status and phase: Completed; Phase 2

Conditions: Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus

Treatments: Drug: Nitazoxanide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328925

RM02-3022

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Nitazoxanide Oral Suspension

Experimental group

Description:

Nitazoxanide Oral Suspension 100 mg/5 ml

Treatment:

Drug: Nitazoxanide

Placebo Oral Suspension

Placebo Comparator group

Description:

Placebo Oral Suspension

Treatment:

Drug: Nitazoxanide