Study of Nitazoxanide in the Treatment of Amebiasis in Children

This study has been completed.

First Received on August 18, 2006. No Changes Posted

Sponsor:	Romark Laboratories L.C.
Information provided by:	Romark Laboratories L.C.
ClinicalTrials.gov Identifier:	NCT00366730

Purpose

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

Condition	Intervention	Phase
Amebiasis	Drug: Nitazoxanide	Phase III

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 Entamoeba Histolytica in Children

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Nitazoxanide

U.S. FDA Resources

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

Primary Outcome Measures:

Resolution of clinical symptoms of amebiasis

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	February 2004
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	1 Year to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366730

Locations

Egypt
University Hospital
Alexandria, Egypt
Benha University Hospital
Benha, Egypt

Sponsors and Collaborators

Romark Laboratories L.C.

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00366730 History of Changes
Other Study ID Numbers:	RM02-3014
Study First Received:	August 18, 2006
Last Updated:	August 18, 2006
Health Authority:	Egypt: Ministry of Health and Population

Keywords provided by Romark Laboratories L.C.:

Amebiasis
Entamoeba histolytica

Additional relevant MeSH terms:

Amebiasis
Dysentery, Amebic
Protozoan Infections
Parasitic Diseases
Intestinal Diseases, Parasitic
Dysentery
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Intestinal Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012