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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00302640
• Date of registration: 13/03/2006
• Primary sponsor: Romark Laboratories L.C.
• Public title: Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
• Scientific title: Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
• Date of first enrolment: February 2005
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00302640
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Mona Abu-Zekry, MD
• Affiliation: Cairo University Children's Hospital, Cairo, Egypt

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adenoviridae Infection

Norovirus Infection

Rotavirus Infection

Intervention(s)

Drug: Alinia (nitazoxanide)

Primary Outcome(s)

Time from first dose to resolution of symptoms. [Time Frame: P-0.0105]

Secondary Outcome(s)

Virologic response (negative ELISA) at day 7-10.

Secondary ID(s)

RM02-3021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors