Study of Nitazoxanide in the Treatment of Amebiasis in Children - Tabular View

Tracking Information

First Received Date ^ICMJE

August 18, 2006

Last Updated Date

August 18, 2006

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Resolution of clinical symptoms of amebiasis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Time from initiation of treatment to passage of last unformed stool

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Nitazoxanide in the Treatment of Amebiasis in Children

Official Title ^ICMJE

Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children

Brief Summary

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Amebiasis

Intervention ^ICMJE

Drug: Nitazoxanide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 1 to 11 years.
Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

Patients with identified causes of diarrhea other than E. histolytica.
Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
Females who are pregnant, suspected of being pregnant or breastfeeding.
Serious systemic disorders incompatible with the study.
History of hypersensitivity to nitazoxanide.
Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
Patients with amebic liver abscess.
Patients known to have or suspected of having AIDS.
Patient with immune deficiencies.

Gender

Both

Ages

1 Year to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Egypt

Administrative Information

NCT ID ^ICMJE

NCT00366730

Responsible Party

Study ID Numbers ^ICMJE

RM02-3014

Study Sponsor ^ICMJE

Romark Laboratories L.C.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Samir M Kabil, MD	Benha University Hospital
Principal Investigator:	Yehia El-Gohary, MD	Alexandria University Hospital

Information Provided By

Romark Laboratories L.C.

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP