Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

• Sponsor: Romark Laboratories L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00366236
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Duration (Months): 21
• Patients Per Site: 25
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.

Condition or Disease	Intervention/Treatment	Phase
Amebiasis	Drug: Nitazoxanide	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents
• Study Start Date: Feb 1, 2004
• Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. Resolution of clinical symptoms of amebiasis []

Secondary Outcome Measures

1. Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples []

2. Time from initiation of treatment to passage of last unformed stool []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥12 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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Alexandria		Egypt
2	Benha University Hospital	Benha		Egypt

Sponsors and Collaborators

• Romark Laboratories L.C.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00366236
• Other Study ID Numbers: RM01-3017
• First Posted: Aug 21, 2006
• Last Update Posted: Aug 21, 2006
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: Amebiasis; Entamoeba histolytica
• Additional relevant MeSH terms: Amebiasis; Dysentery, Amebic; Nitazoxanide

Study Results

No Results Posted as of Aug 21, 2006