Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Diarrhoea Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352716
• Other study ID #: 2-31-00250-100
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: February 1, 2007

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 1, 2007
• Est. primary completion date: February 1, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Month to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea

Intervention

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

Locations

Country	Name	City	State
Peru	Instituto Especializado de Salud del Niño	Breña
Peru	Hospital de Vitarte	Cercado
Peru	Hospital General de Huacho	Huacho
Peru	Hospital Regional de Ica	Ica
Peru	Hospital Nacional Hipólato Unanue	La Molina
Peru	Clinica San Juan Bautista	Lima
Peru	Clinica San Pablo Sede Norte	Lima
Peru	Hospital Municipal Los Olivos	Lima
Peru	Hospital San Bartolomé	Lima
Peru	Hospital San Juan de Lurigancho	Lima
Peru	Hospital Nacional Cayetano Heredia	San Borga
Peru	Hospital Nacional Daniel Alcides Carrión	San Miguel
Peru	Hospital Emergencias Pediátricas	Zárate

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative faecal output (g/kg of body weight)		72 hours after first study drug intake
Secondary	Cumulative faecal output (g)		72 hours after first study drug intake
Secondary	Faecal output (g/kg of body weight) per day		72 hours after first study drug intake
Secondary	Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)		7 days after first study drug intake
Secondary	Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)		7 days after first study drug intake
Secondary	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
Secondary	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
Secondary	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
Secondary	Tolerance of Smecta (assessed via adverse event reporting)		Till 7 days after the end of treatment