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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01328925
Other study ID # RM02-3022
Secondary ID
Status Completed
Phase Phase 2
First received March 29, 2011
Last updated April 1, 2011
Start date December 2005
Est. completion date June 2006

Study information

Verified date April 2011
Source Romark Laboratories L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- Age < 6 years.

- Patients with diarrhea (defined as 3 or more liquid stools per day).

- Stool positive for rotavirus by ELISA.

Exclusion Criteria:

- Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).

- Serious systemic disorders incompatible with the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nitazoxanide
Nitazoxanide Oral Suspension dose based on age: Age <12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days

Locations

Country Name City State
Egypt Cairo University Children's Hospital Cairo

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 Time from first dose to resolution of symptoms. Resolution of all gastrointestinal symptoms associated with viral diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 48 hours to be considered valid. Up to 14 days No
Secondary Time from first dose to virologic response Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days. Up to 14 days No
Secondary Time from first dose to hospital discharge For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital. Up to 14 days No
Secondary Volume of oral rehydration solutions consumed Up to 14 days No
Secondary Frequency of intravenous rehydration required Up to 14 days No
Secondary Stool weight Up to 14 days No
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