Clinical trial NCT00352716: Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhoea
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 300
Sex: MALE
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative faecal output (g/kg of body weight)
timeFrame: 72 hours after first study drug intake
Secondary outcomes:
measure: Cumulative faecal output (g)
timeFrame: 72 hours after first study drug intake
measure: Faecal output (g/kg of body weight) per day
timeFrame: 72 hours after first study drug intake
measure: Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
timeFrame: 7 days after first study drug intake
measure: Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
timeFrame: 7 days after first study drug intake
measure: Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion
timeFrame: Till 7 days after the first study drug intake
measure: Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)
timeFrame: Till 7 days after first study drug intake
measure: 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
timeFrame: Till 7 days after first study drug intake
measure: Tolerance of Smecta (assessed via adverse event reporting)
timeFrame: Till 7 days after the end of treatment
Other outcomes:
Locations:
city: Breña
country: Peru
facility: Instituto Especializado de Salud del Niño
city: Cercado
country: Peru
facility: Hospital de Vitarte
city: Huacho
country: Peru
facility: Hospital General de Huacho
city: Ica
country: Peru
facility: Hospital Regional de Ica
city: La Molina
country: Peru
facility: Hospital Nacional Hipólato Unanue
city: Lima
country: Peru
facility: Clinica San Juan Bautista
city: Lima
country: Peru
facility: Clinica San Pablo Sede Norte
city: Lima
country: Peru
facility: Hospital Municipal Los Olivos
city: Lima
country: Peru
facility: Hospital San Bartolomé
city: Lima
country: Peru
facility: Hospital San Juan de Lurigancho
city: San Borga
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: San Miguel
country: Peru
facility: Hospital Nacional Daniel Alcides Carrión
city: Zárate
country: Peru
facility: Hospital Emergencias Pediátricas
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: