Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

April 1, 2011 updated by: Romark Laboratories L.C.

Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Children'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nitazoxanide Oral Suspension
Nitazoxanide Oral Suspension 100 mg/5 ml
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

Other Names:
  • Alinia
  • NTZ
PLACEBO_COMPARATOR: Placebo Oral Suspension
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

Other Names:
  • Alinia
  • NTZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from first dose to resolution of symptoms.
Time Frame: Up to 14 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from first dose to virologic response
Time Frame: Up to 14 days
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
Time from first dose to hospital discharge
Time Frame: Up to 14 days
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
Volume of oral rehydration solutions consumed
Time Frame: Up to 14 days
Up to 14 days
Frequency of intravenous rehydration required
Time Frame: Up to 14 days
Up to 14 days
Stool weight
Time Frame: Up to 14 days
Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

  • Principal Investigator: Mona Abu-Zekry, MD, Cairo University Children'S Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (ESTIMATE)

April 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM02-3022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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