Study of Nitazoxanide in the Treatment of Amebiasis in Children

Amebiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366730
• Other study ID #: RM02-3014
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: August 18, 2006
• Start date: February 2004
• Est. completion date: November 2005

Study information

• Verified date: August 2006
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amebiasis

Intervention

Drug:
• Nitazoxanide

Locations

Country	Name	City	State
Egypt	University Hospital	Alexandria
Egypt	Benha University Hospital	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of clinical symptoms of amebiasis
Secondary	Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Secondary	Time from initiation of treatment to passage of last unformed stool