Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-02-01

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.

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Detailed Description

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Conditions

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Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Smecta (Diosmectite), duration of treatment - 7 days

Intervention Type DRUG

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

36 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No