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Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

Primary Purpose

Diarrhoea

Status
Completed
Phase
Phase 3
Locations
Malaysia
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 1 watery stool for 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

Sites / Locations

  • Kluang Hospital
  • Kajang Hospital
  • Kulim Hospital
  • Temerloh Hospital
  • Seri Manjung Hospital
  • Teluk Intan Hospital
  • Alor Setar Hospital
  • Ipoh Hospital
  • Raja Perempuan Zainab II Hospital
  • Kuala Terengganu Hospital
  • Tengku Ampuan Afzan Hospital
  • Sarawak General Hospital
  • Malacca Hospital
  • Tuanku Jaafar Hospital
  • Pulau Pinang Hospital
  • Tengku Ampuan Rahimah Hospital
  • Serdang Hospital
  • Sungai Petani Hospital
  • Taiping Hospital

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Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)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 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
NCT00352989
Brief Title
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
Official Title
Efficacy of Diosmectite (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
July 2006 (undefined)
Primary Completion Date
March 24, 2007 (Actual)
Study Completion Date
March 24, 2007 (Actual)

3. Sponsor/Collaborators

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
302 (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 the first study drug intake
Title
Faecal output (g/kg of body weight) per day
Time Frame
72 hours after the first study drug intake
Title
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
Time Frame
7 days after the 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 the first study drug intake
Title
Percentage of body weight gain 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 last study drug intake

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 1 watery stool for 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
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
Kluang Hospital
City
Kluang
State/Province
Johor
ZIP/Postal Code
86000
Country
Malaysia
Facility Name
Kajang Hospital
City
Jalan Semenyih
State/Province
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Kulim Hospital
City
Jalan Mahang
State/Province
Kedah
ZIP/Postal Code
09000
Country
Malaysia
Facility Name
Temerloh Hospital
City
Hospital Sultan Haji Ahmad Shah
State/Province
Pahang
ZIP/Postal Code
28000
Country
Malaysia
Facility Name
Seri Manjung Hospital
City
Seri Manjung
State/Province
Perak
ZIP/Postal Code
28000
Country
Malaysia
Facility Name
Teluk Intan Hospital
City
Teluk Intan
State/Province
Perak
ZIP/Postal Code
36000
Country
Malaysia
Facility Name
Alor Setar Hospital
City
Alor Setar Kedah
ZIP/Postal Code
05100
Country
Malaysia
Facility Name
Ipoh Hospital
City
Ipoh - Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Raja Perempuan Zainab II Hospital
City
Kelantan
ZIP/Postal Code
15000
Country
Malaysia
Facility Name
Kuala Terengganu Hospital
City
Kuala Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
Tengku Ampuan Afzan Hospital
City
Kuantan Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Malacca Hospital
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Facility Name
Tuanku Jaafar Hospital
City
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Pulau Pinang Hospital
City
Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Tengku Ampuan Rahimah Hospital
City
Selangor
ZIP/Postal Code
41200
Country
Malaysia
Facility Name
Serdang Hospital
City
Selangor
ZIP/Postal Code
43300
Country
Malaysia
Facility Name
Sungai Petani Hospital
City
Sungai Petani
ZIP/Postal Code
08000
Country
Malaysia
Facility Name
Taiping Hospital
City
Taiping Perak
ZIP/Postal Code
34000
Country
Malaysia

12. IPD Sharing Statement

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Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

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