Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

• Status: Completed
• Trial end date: 2007-03-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

Inclusion Criteria:

• 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 Criteria:

• severe dehydration that needs IV therapy

• presence of gross blood in stools

• fever >39 degrees Celsius