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

Rotavirus Infection Clinical Trial

Official title:

Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302640
• Other study ID #: RM02-3021
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 13, 2006
• Last updated: May 30, 2012
• Start date: February 2005
• Est. completion date: September 2005

Study information

• Verified date: May 2012
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviridae Infection
• Adenoviridae Infections
• Communicable Diseases
• Infection
• Norovirus Infection
• Rotavirus Infection
• Rotavirus Infections

Intervention

Drug:
• Alinia (nitazoxanide)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

References & Publications (1)

Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from first dose to resolution of symptoms.	Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group	P-0.0105	No
Secondary	Virologic response (negative ELISA) at day 7-10.