Amebiasis Clinical Trial
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
Verified date | August 2006 |
Source | Romark Laboratories L.C. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Health and Population |
Study type | Interventional |
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | University Hospital | Alexandria | |
Egypt | Benha University Hospital | Benha |
Lead Sponsor | Collaborator |
---|---|
Romark Laboratories L.C. |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of clinical symptoms of amebiasis | |||
Secondary | Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples | |||
Secondary | Time from initiation of treatment to passage of last unformed stool |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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