Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Phase 3

Completed

• Conditions: Diarrhoea

• Registration Number: NCT00352716
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Primary Completion: 2007-02-01
• Study Completion: 2007-02-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative faecal output (g/kg of body weight)	72 hours after first study drug intake

Secondary Outcome Measures

Name	Time	Method
Cumulative faecal output (g)	72 hours 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Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)	7 days after first study drug intake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
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 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

Trial Locations

Locations (13)

Hospital Regional de Ica; 🇵🇪 Ica, Peru

Hospital Nacional Daniel Alcides Carrión; 🇵🇪 San Miguel, Peru

Clinica San Pablo Sede Norte; 🇵🇪 Lima, Peru

Hospital Emergencias Pediátricas; 🇵🇪 Zárate, Peru

Instituto Especializado de Salud del Niño; 🇵🇪 Breña, Peru

Clinica San Juan Bautista; 🇵🇪 Lima, Peru

Hospital General de Huacho; 🇵🇪 Huacho, Peru

Hospital de Vitarte; 🇵🇪 Cercado, Peru

Hospital Nacional Hipólato Unanue; 🇵🇪 La Molina, Peru

Hospital Municipal Los Olivos; 🇵🇪 Lima, Peru

Hospital San Juan de Lurigancho; 🇵🇪 Lima, Peru

Hospital San Bartolomé; 🇵🇪 Lima, Peru

Hospital Nacional Cayetano Heredia; 🇵🇪 San Borga, Peru