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

This study has been completed.

Sponsor:

Information provided by:

Ipsen

ClinicalTrials.gov Identifier:

NCT00352989

First received: July 13, 2006

Last updated: September 26, 2007

Last verified: September 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2006

Last Updated Date

September 26, 2007

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cumulative faecal output (g/kg of body weight) over the first 72 hours of treatment with Smecta

Change History

Complete list of historical versions of study NCT00352989 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cumulative faecal output (g) [ Time Frame: 72 hours after the first study drug intake ]
Faecal output (g/kg of body weight) per day [ Time Frame: 72 hours after the first study drug intake ]
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) [ Time Frame: 7 days after the first study drug intake ]
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) [ Time Frame: 7 days after the first study drug intake ]
Percentage of body weight gain 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 last study drug intake ]

Original Secondary Outcome Measures ^ICMJE

Cumulative faecal output (g) during first 72 hours
Faecal output (g/kg of body weight) per day, for first 72 hours
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Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)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)

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Diarrhoea

Intervention ^ICMJE

Drug: Smecta (Diosmectite), duration of treatment - 7 days

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

1 Month to 36 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Malaysia

Administrative Information

NCT Number ^ICMJE

NCT00352989

Other Study ID Numbers ^ICMJE

2-31-00250-101

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Philippe Garnier, MD

Ipsen

Information Provided By

Ipsen

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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