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

NCT ID: NCT00302640

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rotavirus Infection Adenoviridae Infection Norovirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Nitazoxanide

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

Group Type ACTIVE_COMPARATOR

Alinia (nitazoxanide)

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Alinia (nitazoxanide)

Intervention Type DRUG

Interventions

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Alinia (nitazoxanide)

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Romark Laboratories L.C.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mona Abu-Zekry, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University Children's Hospital, Cairo, Egypt

References

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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. doi: 10.1016/S0140-6736(06)68852-1.

Reference Type RESULT
PMID: 16829296 (View on PubMed)

Other Identifiers

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RM02-3021

Identifier Type: -

Identifier Source: org_study_id