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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00366236
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : August 21, 2006
Information provided by:
Romark Laboratories L.C.

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.

Condition or disease Intervention/treatment Phase
Amebiasis Drug: Nitazoxanide Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : February 2004
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Resolution of clinical symptoms of amebiasis

Secondary Outcome Measures :
  1. Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
  2. Time from initiation of treatment to passage of last unformed stool

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00366236     History of Changes
Other Study ID Numbers: RM01-3017
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: August 21, 2006
Last Verified: August 2006

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