Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo, Controlled, Randomized, Double-blind, Parallel Groups, Multicenter Study.

Conditions
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Diarrhoea

Intervention / Treatment
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* Drug: Smecta (Diosmectite), duration of treatment - 7 days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 36 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Smecta (Diosmectite), duration of treatment - 7 days|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative faecal output (g/kg of body weight) |  | 72 hours after first study drug intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative faecal output (g) |  | 72 hours after first study drug intake | 
| Faecal output (g/kg of body weight) per day |  | 72 hours after first study drug intake | 
| Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) |  | 7 days after first study drug intake | 
| Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) |  | 7 days after first study drug intake | 
| Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion |  | Till 7 days after the first study drug intake | 
| Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7) |  | Till 7 days after first study drug intake | 
| Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale |  | Till 7 days after first study drug intake | 
| Tolerance of Smecta (assessed via adverse event reporting) |  | Till 7 days after the end of treatment |