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

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00302640
First received: March 13, 2006
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rotavirus Infection
Adenoviridae Infection
Norovirus Infection
 Drug: Alinia (nitazoxanide)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Time from first dose to resolution of symptoms. [ Time Frame: P-0.0105 ] [ Designated as safety issue: No ]
    Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group


Secondary Outcome Measures:
  • Virologic response (negative ELISA) at day 7-10.

Enrollment: 50
Study Start Date: February 2005
Estimated Study Completion Date: September 2005
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302640

Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Mona Abu-Zekry, MD Cairo University Children's Hospital, Cairo, Egypt
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00302640     History of Changes
Other Study ID Numbers: RM02-3021
Study First Received: March 13, 2006
Last Updated: May 30, 2012
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Adenoviridae Infections
Diarrhea
Rotavirus Infections
DNA Virus Infections
Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
 Reoviridae Infections
RNA Virus Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013