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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366236
Other study ID # RM01-3017
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2006
Last updated August 18, 2006
Start date February 2004
Est. completion date November 2005

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nitazoxanide


Locations

Country Name City State
Egypt University Hospital Alexandria
Egypt Benha University Hospital Benha

Sponsors (1)

Lead Sponsor Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT00001162 - Parasitic Infections of the Gastrointestinal Tract N/A
Completed NCT02734264 - Field Studies of Amebiasis in Bangladesh N/A
Completed NCT00366730 - Study of Nitazoxanide in the Treatment of Amebiasis in Children Phase 3