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

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00366236
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 tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.


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 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: 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.:
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 July 29, 2014