CompletedPhase 3

Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Peru300 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range1 Month – 36 Months

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 one watery stool during 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 * current treatment by an antidiarrheal medication

What they're measuring

Cumulative faecal output (g/kg of body weight)

Timeframe: 72 hours after first study drug intake

Trial details

NCT IDNCT00352716

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02-01

View on ClinicalTrials.gov More Diarrhoea trials