Back to resultsEfficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Primary Purpose
Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
About this trial
This is an interventional treatment trial for Rotavirus Infection focused on measuring Rotavirus, Viral gastroenteritis, Gastroenteritis
Eligibility Criteria
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.
Sites / Locations
- Cairo University Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitazoxanide Oral Suspension
Placebo Oral Suspension
Arm Description
Nitazoxanide Oral Suspension 100 mg/5 ml
Placebo Oral Suspension
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Volume of oral rehydration solutions consumed
Frequency of intravenous rehydration required
Stool weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01328925
Brief Title
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Official Title
Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
Keywords
Rotavirus, Viral gastroenteritis, Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide Oral Suspension
Arm Type
Experimental
Arm Description
Nitazoxanide Oral Suspension 100 mg/5 ml
Arm Title
Placebo Oral Suspension
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Suspension
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia, NTZ
Intervention Description
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
Primary Outcome Measure Information:
Title
Time from first dose to resolution of symptoms.
Description
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.
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Time from first dose to virologic response
Description
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.
Time Frame
Up to 14 days
Title
Time from first dose to hospital discharge
Description
For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.
Time Frame
Up to 14 days
Title
Volume of oral rehydration solutions consumed
Time Frame
Up to 14 days
Title
Frequency of intravenous rehydration required
Time Frame
Up to 14 days
Title
Stool weight
Time Frame
Up to 14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Abu-Zekry, MD
Organizational Affiliation
Cairo University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Children's Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
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