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

May 30, 2012 updated by: Romark Laboratories L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Drug: Alinia (nitazoxanide)
PLACEBO_COMPARATOR: 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
Drug: Alinia (nitazoxanide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from first dose to resolution of symptoms.
Time Frame: P-0.0105
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
P-0.0105

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

  • Principal Investigator: Mona Abu-Zekry, MD, Cairo University Children's Hospital, Cairo, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (ESTIMATE)

March 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM02-3021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotavirus Infection

Clinical Trials on Alinia (nitazoxanide)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe