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

This study has been completed.

Sponsored by:	Romark Laboratories L.C.
Information provided by:	Romark Laboratories L.C.
ClinicalTrials.gov Identifier:	NCT00366236

Purpose

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	Intervention	Phase
Amebiasis	Drug: Nitazoxanide	Phase III

MedlinePlus related topics: Diarrhea

Drug Information available for: Nitazoxanide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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

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:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366236

Locations

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

More Information

Study ID Numbers:	RM01-3017
Study First Received:	August 18, 2006
Last Updated:	August 18, 2006
ClinicalTrials.gov Identifier:	NCT00366236
Health Authority:	Egypt: Ministry of Health and Population

Keywords provided by Romark Laboratories L.C.:

Amebiasis
Entamoeba histolytica

Study placed in the following topic categories:

Protozoan Infections
Amebiasis
Diarrhea
Parasitic Diseases
Nitazoxanide

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Therapeutic Uses

Sarcodina Infections
Sarcomastigophora Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009