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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Diarrhoea

Treatments: Drug: Smecta (Diosmectite), duration of treatment - 7 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352989

2-31-00250-101

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: Male

Ages: 1 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind