NCT00276328

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2005

Geographic Reach
2 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

First QC Date

January 12, 2006

Last Update Submit

April 27, 2020

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • 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)

Interventions

Diosmectite (Smecta®)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Cabinet Médical, 50 rue Tata

Casablanca, 20000, Morocco

Location

Cabinet Medical, 17 Boulevard Bir Anzaran

Casablanca, 20200, Morocco

Location

Cabinet Médical, 12 rue Reaumur

Casablanca, 20200, Morocco

Location

Cabinet Médical, 94 boulevard du 11 janvier

Casablanca, 20200, Morocco

Location

Hopital Ibn Roched

Casablanca, 20200, Morocco

Location

Hôpital Ben Msick Sidi Othmane

Casablanca, 20200, Morocco

Location

Hôpital Avicenne

Rabat, 99, Morocco

Location

Hopital régional de Ben Arous

Ben Arous, 2013, Tunisia

Location

Hôpital des F.S.I.

La Marsa, 2070, Tunisia

Location

Hôpital Régional de Menzel

Menzel Bourguiba, 7050, Tunisia

Location

Hôpital Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

Hôpital Régional

Nabeul, 8000, Tunisia

Location

Hôpital Hédi Chaker

Sfax, 3029, Tunisia

Location

avenue du 20 mars 1956 - Cité Jawhara

Sousse, 4000, Tunisia

Location

Cité Laouina

Sousse, 4000, Tunisia

Location

rue Abou Baker Essadik

Sousse, 4000, Tunisia

Location

rue Alexandre Dumas

Sousse, 4000, Tunisia

Location

rue Sidi Sahloul - Hammam

Sousse, 4011, Tunisia

Location

rue Ali Ibn Taleb - Messadine

Sousse, 4013, Tunisia

Location

Avenue Habib Bourguiba - Kalaa Essghira

Sousse, 4021, Tunisia

Location

Avenue Habib Bourguiba - Sidi Bou Ali

Sousse, 4040, Tunisia

Location

Cité Sahloul, route principale, AFH No.9

Sousse, 4054, Tunisia

Location

Hôpital Sahloul

Sousse, 4054, Tunisia

Location

rue du 1 er juin - Kalaa Kebira

Sousse, 4060, Tunisia

Location

Polyclinique Taoufik

Tunis, 1002, Tunisia

Location

Rue Micipsa

Tunis, 1002, Tunisia

Location

Hôpital Charles Nicolle

Tunis, 1006, Tunisia

Location

Hôpital La Rabta

Tunis, 1007, Tunisia

Location

Hôpital Habib Thameur

Tunis, 1008, Tunisia

Location

Hôpital Militaire

Tunis, 1008, Tunisia

Location

Polyclinique de la CNSS

Tunis, 1008, Tunisia

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Smectitesmecta

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

January 1, 2005

Study Completion

July 1, 2006

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

TU(24)MO(7)