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Sponsored by: |
Ipsen |
---|---|
Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00352716 |
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.
Condition | Intervention | Phase |
---|---|---|
Diarrhoea |
Drug: Smecta (Diosmectite), duration of treatment - 7 days |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children |
Estimated Enrollment: | 300 |
Study Start Date: | June 2006 |
Ages Eligible for Study: | 1 Month to 36 Months |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Peru | |
Hospital Nacional Cayetano Heredia | |
San Borga, Peru | |
Instituto Especializado de Salud del Niño | |
Breña, Peru | |
Hospital Nacional Hipólato Unanue | |
La Molina, Peru | |
Hospital Emergencias Pediátricas | |
Zárate, Peru | |
Hospital Nacional Daniel Alcides Carrión | |
San Miguel, Peru | |
Hospital de Vitarte | |
Cercado, Peru | |
Clinica San Pablo Sede Norte | |
Lima, Peru | |
Hospital Municipal Los Olivos | |
Lima, Peru | |
Hospital San Juan de Lurigancho | |
Lima, Peru | |
Hospital General de Huacho | |
Huacho, Peru | |
Hospital Regional de Ica | |
Ica, Peru | |
Clinica San Juan Bautista | |
Lima, Peru | |
Hospital San Bartolomé | |
Lima, Peru |
Study Director: | Philippe Garnier, MD | Ipsen |
Study ID Numbers: | 2-31-00250-100 |
Study First Received: | July 13, 2006 |
Last Updated: | September 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00352716 |
Health Authority: | Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |