Status:
COMPLETED
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
Lead Sponsor:
Ipsen
Conditions:
Diarrhoea
Eligibility:
MALE
1-36 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
Eligibility Criteria
Inclusion
- male
- acute watery diarrhoea defined as at least 3 watery stools per 24 hours
- duration of watery diarrhoea of less than 72 hours and with at least one watery stool during the last 12 hours
- dehydration signs requiring oral rehydration according to current WHO guidelines
Exclusion
- severe dehydration that needs IV therapy
- presence of gross blood in stools
- fever \> 39 degrees Celsius
- current treatment by an antidiarrheal medication
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00352716
Start Date
June 1 2006
End Date
February 1 2007
Last Update
November 22 2019
Active Locations (13)
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1
Instituto Especializado de Salud del Niño
Breña, Peru
2
Hospital de Vitarte
Cercado, Peru
3
Hospital General de Huacho
Huacho, Peru
4
Hospital Regional de Ica
Ica, Peru