Completed

Diosmectite (Smecta®) for Acute Diarrhoea Recovery in Adults

What is being tested

Data Collection

Who is being recruted

Diarrhea+1

+ Signs and Symptoms

+ Signs and Symptoms, Digestive

From 18 to 65 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: January 2005

See protocol details

Summary

Principal SponsorIpsen

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

This study focuses on treating acute diarrhea in adults. It aims to find out if a medication called Smecta® works better than a placebo (a pill with no active ingredients) in helping patients recover quicker from an episode of acute diarrhea. The importance of this research lies in the potential to improve treatment options for this common condition, helping patients feel better faster and reducing potential complications associated with prolonged diarrhea. Participants in this study will take Smecta® or a placebo. The main measurement of success is the time it takes from the first dose until the patient has a formed stool, which must be followed by a non-watery stool. This will help determine if Smecta® speeds up recovery time. As with any study, there may be potential risks and benefits associated with participation.

Official TitleEfficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.

NCT00276328

Principal SponsorIpsen

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

346 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DiarrheaSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate

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

4 exclusion criteria prevent from participating

History of chronic diarrhoea or motor diarrhoea

Gross blood, pus in the stools

Fever >39ºC

Other episode of acute watery diarrhoea within the last 30 days

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 31 locations

Suspended

Cabinet Médical, 50 rue Tata

Casablanca, MoroccoOpen Cabinet Médical, 50 rue Tata in Google Maps

Suspended

Cabinet Medical, 17 Boulevard Bir Anzaran

Casablanca, Morocco

Suspended

Cabinet Médical, 12 rue Reaumur

Casablanca, Morocco

Suspended

Cabinet Médical, 94 boulevard du 11 janvier

Casablanca, Morocco

Completed31 Study Centers