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

April 27, 2020 updated by: Ipsen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Casablanca, Morocco, 20000
        • Cabinet Médical, 50 rue Tata
      • Casablanca, Morocco, 20200
        • Cabinet Medical, 17 Boulevard Bir Anzaran
      • Casablanca, Morocco, 20200
        • Cabinet Médical, 12 rue Reaumur
      • Casablanca, Morocco, 20200
        • Cabinet Médical, 94 boulevard du 11 janvier
      • Casablanca, Morocco, 20200
        • Hopital Ibn Roched
      • Casablanca, Morocco, 20200
        • Hôpital Ben Msick Sidi Othmane
      • Rabat, Morocco, 99
        • Hôpital Avicenne
  • Tunisia
      • Ben Arous, Tunisia, 2013
        • Hopital régional de Ben Arous
      • La Marsa, Tunisia, 2070
        • Hôpital des F.S.I.
      • Menzel Bourguiba, Tunisia, 7050
        • Hôpital Régional de Menzel
      • Monastir, Tunisia, 5000
        • Hôpital Fattouma Bourguiba
      • Nabeul, Tunisia, 8000
        • Hôpital Régional
      • Sfax, Tunisia, 3029
        • Hôpital Hédi Chaker
      • Sousse, Tunisia, 4000
        • avenue du 20 mars 1956 - Cité Jawhara
      • Sousse, Tunisia, 4000
        • Cité Laouina
      • Sousse, Tunisia, 4000
        • rue Abou Baker Essadik
      • Sousse, Tunisia, 4000
        • rue Alexandre Dumas
      • Sousse, Tunisia, 4011
        • rue Sidi Sahloul - Hammam
      • Sousse, Tunisia, 4013
        • rue Ali Ibn Taleb - Messadine
      • Sousse, Tunisia, 4021
        • Avenue Habib Bourguiba - Kalaa Essghira
      • Sousse, Tunisia, 4040
        • Avenue Habib Bourguiba - Sidi Bou Ali
      • Sousse, Tunisia, 4054
        • Cité Sahloul, route principale, AFH No.9
      • Sousse, Tunisia, 4054
        • Hôpital Sahloul
      • Sousse, Tunisia, 4060
        • rue du 1 er juin - Kalaa Kebira
      • Tunis, Tunisia, 1002
        • Polyclinique Taoufik
      • Tunis, Tunisia, 1002
        • Rue Micipsa
      • Tunis, Tunisia, 1006
        • Hôpital Charles Nicolle
      • Tunis, Tunisia, 1007
        • Hopital La Rabta
      • Tunis, Tunisia, 1008
        • Hopital Habib Thameur
      • Tunis, Tunisia, 1008
        • Hopital Militaire
      • Tunis, Tunisia, 1008
        • Polyclinique de la CNSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-31-00250-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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