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

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 the first study drug intake | 
| Faecal output (g/kg of body weight) per day |  | 72 hours after the first study drug intake | 
| Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) |  | 7 days after the first study drug intake | 
| Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) |  | 7 days after the first study drug intake | 
| Percentage of body weight gain 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 last study drug intake |