Status:
COMPLETED
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and 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 1 watery stool for 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2007
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00352989
Start Date
July 1 2006
End Date
March 24 2007
Last Update
November 22 2019
Active Locations (19)
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1
Kluang Hospital
Kluang, Johor, Malaysia, 86000
2
Kajang Hospital
Jalan Semenyih, Kajang, Malaysia, 43000
3
Kulim Hospital
Jalan Mahang, Kedah, Malaysia, 09000
4
Temerloh Hospital
Hospital Sultan Haji Ahmad Shah, Pahang, Malaysia, 28000