Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Romark Laboratories

Status and phase: Completed; Phase 3; Phase 2

Conditions: Adenoviridae Infection; Rotavirus Infection; Norovirus Infection

Treatments: Drug: Alinia (nitazoxanide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302640

RM02-3021

Details and patient eligibility

About

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

Enrollment: 50 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age <12 years.
• Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
• Stool positive for adenovirus, norovirus or rotavirus by ELISA.

Exclusion criteria

• Females who are pregnant, suspected of being pregnant or breastfeeding.
• Other identified causes of diarrhea at screening.
• Serious systemic disorders incompatible with the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Nitazoxanide

Active Comparator group

Description:

7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days

Treatment:

Drug: Alinia (nitazoxanide)

Placebo

Placebo Comparator group

Description:

7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days

Treatment:

Drug: Alinia (nitazoxanide)