Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedApril 5, 2011
April 1, 2011
6 months
March 29, 2011
April 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Time from first dose to virologic response
Up to 14 days
Time from first dose to hospital discharge
Up to 14 days
Volume of oral rehydration solutions consumed
Up to 14 days
Frequency of intravenous rehydration required
Up to 14 days
Stool weight
Up to 14 days
Study Arms (2)
Nitazoxanide Oral Suspension
EXPERIMENTALNitazoxanide Oral Suspension 100 mg/5 ml
Placebo Oral Suspension
PLACEBO COMPARATORPlacebo Oral Suspension
Interventions
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
Eligibility Criteria
You may qualify if:
- Age \< 6 years.
- Patients with diarrhea (defined as 3 or more liquid stools per day).
- Stool positive for rotavirus by ELISA.
You may not qualify if:
- Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
- Serious systemic disorders incompatible with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo University Children's Hospital
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Abu-Zekry, MD
Cairo University Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 29, 2011
First Posted
April 5, 2011
Study Start
December 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
April 5, 2011
Record last verified: 2011-04