Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents...
Brief Summary
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”
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Nitazoxanide
Outcome Measures for this Clinical Trial
Primary Measures
- Resolution of clinical symptoms of amebiasis
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Romark Laboratories L.C. Industry
Overall Clinical Trial Officials and Contacts
Samir M Kabil, MD Principal Investigator Benha University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00366236
Study ID Number: RM01-3017
ClinicalTrials.gov Identifier: NCT00366236
Health Authority: Egypt: Ministry of Health and Population
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00366236
