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

Primary Purpose

Amebiasis

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
Romark Laboratories L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amebiasis focused on measuring Amebiasis, Entamoeba histolytica

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital
  • Benha University Hospital

Outcomes

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

Full Information

First Posted
August 18, 2006
Last Updated
August 18, 2006
Sponsor
Romark Laboratories L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00366236
Brief Title
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
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 Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Romark Laboratories L.C.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amebiasis
Keywords
Amebiasis, Entamoeba histolytica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Primary Outcome Measure Information:
Title
Resolution of clinical symptoms of amebiasis
Secondary Outcome Measure Information:
Title
Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Title
Time from initiation of treatment to passage of last unformed stool

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir M Kabil, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yehia El-Gohary, MD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Alexandria
Country
Egypt
Facility Name
Benha University Hospital
City
Benha
Country
Egypt

12. IPD Sharing Statement

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

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