Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults

Ipsen346 enrolled

Overview

The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

346

Conditions

Diarrhea

Interventions

Diosmectite (Smecta®)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less * Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day Exclusion Criteria: * Gross blood, pus in the stools * Fever \>39ºC * Other episode of acute watery diarrhoea within the last 30 days * History of chronic diarrhoea or motor diarrhoea

Locations (31)

Cabinet Médical, 50 rue Tata

Outcomes

Primary Outcomes

Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)

Secondary Outcomes

Time (hours) from first sachet intake to the last watery stool

Number of stools and number of watery stools per 12 hour period

% of patients with recovery, per 12 hour period

% of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period

Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)

Data from ClinicalTrials.gov

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