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

Phase 3

Completed

• Conditions: Amebiasis

• Registration Number: NCT00366236
• Lead Sponsor: Romark Laboratories L.C.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study Completion: 2005-11
• Status Verified: 2006-08
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Last Update Submitted: 2006-08-18
• Study First Posted: 2006-08-21
• Last Update Posted: 2006-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Resolution of clinical symptoms of amebiasis

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital; 🇪🇬 Alexandria, Egypt

Benha University Hospital; 🇪🇬 Benha, Egypt