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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00352989
Other study ID # 2-31-00250-101
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2006
Est. completion date March 24, 2007

Study information

Verified date November 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date March 24, 2007
Est. primary completion date March 24, 2007
Accepts healthy volunteers No
Gender Male
Age group 1 Month to 36 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Malaysia Alor Setar Hospital Alor Setar Kedah
Malaysia Temerloh Hospital Hospital Sultan Haji Ahmad Shah Pahang
Malaysia Ipoh Hospital Ipoh - Perak
Malaysia Kulim Hospital Jalan Mahang Kedah
Malaysia Kajang Hospital Jalan Semenyih Kajang
Malaysia Raja Perempuan Zainab II Hospital Kelantan
Malaysia Kluang Hospital Kluang Johor
Malaysia Kuala Terengganu Hospital Kuala Terengganu
Malaysia Tengku Ampuan Afzan Hospital Kuantan Pahang
Malaysia Sarawak General Hospital Kuching
Malaysia Malacca Hospital Melaka
Malaysia Tuanku Jaafar Hospital Negeri Sembilan
Malaysia Pulau Pinang Hospital Pulau Pinang
Malaysia Serdang Hospital Selangor
Malaysia Tengku Ampuan Rahimah Hospital Selangor
Malaysia Seri Manjung Hospital Seri Manjung Perak
Malaysia Sungai Petani Hospital Sungai Petani
Malaysia Taiping Hospital Taiping Perak
Malaysia Teluk Intan Hospital Teluk Intan Perak

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative faecal output (g/kg of body weight) 72 hours after first study drug intake
Secondary Cumulative faecal output (g) 72 hours after the first study drug intake
Secondary Faecal output (g/kg of body weight) per day 72 hours after the first study drug intake
Secondary Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) 7 days after the first study drug intake
Secondary Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) 7 days after the first study drug intake
Secondary Percentage of body weight gain in comparison with body weight at inclusion Till 7 days after the first study drug intake
Secondary Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7) Till 7 days after first study drug intake
Secondary 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 Till 7 days after first study drug intake
Secondary Tolerance of Smecta (assessed via adverse event reporting) Till 7 days after the last study drug intake
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