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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smecta (Diosmectite), duration of treatment - 7 days | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative faecal output (g/kg of body weight) | 72 hours after first study drug intake |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative faecal output (g) | 72 hours after 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Especializado de Salud del Niño | Breña | Peru | ||||
| Hospital de Vitarte |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C016752 | smecta |
| C033214 | Smectite |
| D000081206 | Duration of Therapy |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 7 days 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| Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) | 7 days after first study drug intake |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 |
| 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 |
| 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 | Peru |