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.
Verified date | November 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Peru,
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 |
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