Diarrhea
Conditions
Brief summary
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.
Interventions
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less * Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day
Exclusion criteria
* Gross blood, pus in the stools * Fever \>39ºC * Other episode of acute watery diarrhoea within the last 30 days * History of chronic diarrhoea or motor diarrhoea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time (hours) from first sachet intake to the last watery stool | — |
| Number of stools and number of watery stools per 12 hour period | — |
| % of patients with recovery, per 12 hour period | — |
| % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period | — |
| Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS) | — |
Countries
Morocco, Tunisia
Outcome results
None listed