Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00352716
First received: July 13, 2006
Last updated: September 26, 2007
Last verified: September 2007
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Cumulative faecal output (g/kg of body weight) [ Time Frame: 72 hours after first study drug intake ]

Secondary Outcome Measures:
  • Cumulative faecal output (g) [ Time Frame: 72 hours after first study drug intake ]
  • Faecal output (g/kg of body weight) per day [ Time Frame: 72 hours after first study drug intake ]
  • Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) [ Time Frame: 7 days after first study drug intake ]
  • Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) [ Time Frame: 7 days after first study drug intake ]
  • Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Till 7 days after first study drug intake ]
  • Tolerance of Smecta (assessed via adverse event reporting) [ Time Frame: Till 7 days after the end of treatment ]

Estimated Enrollment: 300
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352716

Locations
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
Hospital San Bartolomé
Lima, Peru
Clinica San Pablo Sede Norte
Lima, Peru
Hospital Municipal Los Olivos
Lima, Peru
Hospital San Juan de Lurigancho
Lima, Peru
Clinica San Juan Bautista
Lima, Peru
Hospital Nacional Cayetano Heredia
San Borga, Peru
Hospital Nacional Daniel Alcides Carrión
San Miguel, Peru
Hospital Emergencias Pediátricas
Zárate, Peru
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Philippe Garnier, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00352716     History of Changes
Other Study ID Numbers: 2-31-00250-100
Study First Received: July 13, 2006
Last Updated: September 26, 2007
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014