Study of Nitazoxanide in the Treatment of Amebiasis in Ad... | NCT00366236

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

NCT00366236

Sponsor

Romark Laboratories L.C.

Status

Completed

Last Update Posted

Aug 21, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Amebiasis

Interventions

Nitazoxanide

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Aug 18, 2006

First Submission Date that Met QC Criteria

Aug 18, 2006

First Posted Date

Aug 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2006

Last Update Posted Date

Aug 21, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of clinical symptoms of amebiasis

Secondary Outcomes

Measure	Description	Time Frame
Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Time from initiation of treatment to passage of last unformed stool

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samir M Kabil, MD	Benha University	Principal Investigator
Yehia El-Gohary, MD	Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Alexandria			Egypt
Benha University Hospital

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections