Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

Efficacy of 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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00352716

Enrollment

300

Registered

2006-07-17

Start date

2006-06-30

Completion date

2007-02-01

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea

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.

Interventions

DRUGSmecta (Diosmectite), duration of treatment - 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

1 Months to 36 Months

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 one watery stool during 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 * current treatment by an antidiarrheal medication

Design outcomes

Primary

Measure	Time frame
Cumulative faecal output (g/kg of body weight)	72 hours after first study drug intake

Secondary

Measure	Time frame
Faecal output (g/kg of body weight) per day	72 hours after first study drug intake
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)	7 days after first study drug intake
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)	7 days after first study drug intake
Cumulative faecal output (g)	72 hours after first study drug intake
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
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
Tolerance of Smecta (assessed via adverse event reporting)	Till 7 days after the end of treatment
Percentage of body weight gain at H72 and Day 7 in comparison with body weight at inclusion	Till 7 days after the first study drug intake

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026