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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00302640
Other study ID # RM02-3021
Secondary ID
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
Est. primary completion date
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


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.
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