Clinical trial NCT00352989: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhoea
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 302
Sex: MALE
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cumulative faecal output (g/kg of body weight)
timeFrame: 72 hours after first study drug intake
Secondary outcomes:
measure: Cumulative faecal output (g)
timeFrame: 72 hours after the first study drug intake
measure: Faecal output (g/kg of body weight) per day
timeFrame: 72 hours after the first study drug intake
measure: Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
timeFrame: 7 days after the first study drug intake
measure: Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
timeFrame: 7 days after the first study drug intake
measure: Percentage of body weight gain in comparison with body weight at inclusion
timeFrame: Till 7 days after the first study drug intake
measure: Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)
timeFrame: Till 7 days after first study drug intake
measure: 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
timeFrame: Till 7 days after first study drug intake
measure: Tolerance of Smecta (assessed via adverse event reporting)
timeFrame: Till 7 days after the last study drug intake
Other outcomes:
Locations:
city: Kluang
country: Malaysia
facility: Kluang Hospital
state: Johor
city: Jalan Semenyih
country: Malaysia
facility: Kajang Hospital
state: Kajang
city: Jalan Mahang
country: Malaysia
facility: Kulim Hospital
state: Kedah
city: Hospital Sultan Haji Ahmad Shah
country: Malaysia
facility: Temerloh Hospital
state: Pahang
city: Seri Manjung
country: Malaysia
facility: Seri Manjung Hospital
state: Perak
city: Teluk Intan
country: Malaysia
facility: Teluk Intan Hospital
state: Perak
city: Alor Setar Kedah
country: Malaysia
facility: Alor Setar Hospital
city: Ipoh - Perak
country: Malaysia
facility: Ipoh Hospital
city: Kelantan
country: Malaysia
facility: Raja Perempuan Zainab II Hospital
city: Kuala Terengganu
country: Malaysia
facility: Kuala Terengganu Hospital
city: Kuantan Pahang
country: Malaysia
facility: Tengku Ampuan Afzan Hospital
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Melaka
country: Malaysia
facility: Malacca Hospital
city: Negeri Sembilan
country: Malaysia
facility: Tuanku Jaafar Hospital
city: Pulau Pinang
country: Malaysia
facility: Pulau Pinang Hospital
city: Selangor
country: Malaysia
facility: Tengku Ampuan Rahimah Hospital
city: Selangor
country: Malaysia
facility: Serdang Hospital
city: Sungai Petani
country: Malaysia
facility: Sungai Petani Hospital
city: Taiping Perak
country: Malaysia
facility: Taiping Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: