Trial record 1 of 8 for:    "Amebiasis"
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Study of Nitazoxanide in the Treatment of Amebiasis in Children

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00366730
First received: August 18, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Amebiasis
Drug: Nitazoxanide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children

Resource links provided by NLM:


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:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366730

Locations
Egypt
University Hospital
Alexandria, Egypt
Benha University Hospital
Benha, 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00366730     History of Changes
Other Study ID Numbers: RM02-3014
Study First Received: August 18, 2006
Last Updated: August 18, 2006
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Romark Laboratories L.C.:
Amebiasis
Entamoeba histolytica

Additional relevant MeSH terms:
Amebiasis
Dysentery, Amebic
Protozoan Infections
Parasitic Diseases
Intestinal Diseases, Parasitic
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014