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

Diarrhoea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352989
• Other study ID #: 2-31-00250-101
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea

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