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

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

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
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 Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT00366236

University Hospital
Alexandria, Egypt
Benha University Hospital
Benha, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
Principal Investigator: Samir M Kabil, MD Benha University Hospital
Principal Investigator: Yehia El-Gohary, MD Alexandria University
  More Information

No publications provided Identifier: NCT00366236     History of Changes
Other Study ID Numbers: RM01-3017
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.:
Entamoeba histolytica

Additional relevant MeSH terms:
Dysentery, Amebic
Protozoan Infections
Parasitic Diseases
Intestinal Diseases, Parasitic
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014