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Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Primary Purpose

Diarrhoea

Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
Smecta (Diosmectite), duration of treatment - 7 days
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhoea

Eligibility Criteria

1 Month - 36 Months (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Especializado de Salud del Niño
  • Hospital de Vitarte
  • Hospital General de Huacho
  • Hospital Regional de Ica
  • Hospital Nacional Hipólato Unanue
  • Clinica San Juan Bautista
  • Clinica San Pablo Sede Norte
  • Hospital Municipal Los Olivos
  • Hospital San Bartolomé
  • Hospital San Juan de Lurigancho
  • Hospital Nacional Cayetano Heredia
  • Hospital Nacional Daniel Alcides Carrión
  • Hospital Emergencias Pediátricas

Outcomes

Primary Outcome Measures

Cumulative faecal output (g/kg of body weight)

Secondary Outcome Measures

Cumulative faecal output (g)
Faecal output (g/kg of body weight) per day
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion
Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)
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
Tolerance of Smecta (assessed via adverse event reporting)

Full Information

First Posted
July 13, 2006
Last Updated
November 21, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00352716
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 1, 2007 (Actual)
Study Completion Date
February 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Smecta (Diosmectite), duration of treatment - 7 days
Primary Outcome Measure Information:
Title
Cumulative faecal output (g/kg of body weight)
Time Frame
72 hours after first study drug intake
Secondary Outcome Measure Information:
Title
Cumulative faecal output (g)
Time Frame
72 hours after first study drug intake
Title
Faecal output (g/kg of body weight) per day
Time Frame
72 hours after first study drug intake
Title
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
Time Frame
7 days after first study drug intake
Title
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
Time Frame
7 days after first study drug intake
Title
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
Title
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
Title
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
Title
Tolerance of Smecta (assessed via adverse event reporting)
Time Frame
Till 7 days after the end of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Especializado de Salud del Niño
City
Breña
Country
Peru
Facility Name
Hospital de Vitarte
City
Cercado
Country
Peru
Facility Name
Hospital General de Huacho
City
Huacho
Country
Peru
Facility Name
Hospital Regional de Ica
City
Ica
Country
Peru
Facility Name
Hospital Nacional Hipólato Unanue
City
La Molina
Country
Peru
Facility Name
Clinica San Juan Bautista
City
Lima
Country
Peru
Facility Name
Clinica San Pablo Sede Norte
City
Lima
Country
Peru
Facility Name
Hospital Municipal Los Olivos
City
Lima
Country
Peru
Facility Name
Hospital San Bartolomé
City
Lima
Country
Peru
Facility Name
Hospital San Juan de Lurigancho
City
Lima
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
San Borga
Country
Peru
Facility Name
Hospital Nacional Daniel Alcides Carrión
City
San Miguel
Country
Peru
Facility Name
Hospital Emergencias Pediátricas
City
Zárate
Country
Peru

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

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