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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00276328

Purpose

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.

Condition	Intervention	Phase
Diarrhea	Drug: Diosmectite (Smecta®)	Phase IV

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.

Further study details as provided by Ipsen:

Primary Outcome Measures:

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:

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)

Estimated Enrollment:	280
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276328

Locations

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Philippe Garnier, MD

Ipsen

More Information

Study ID Numbers:	2-31-00250-009
Study First Received:	January 12, 2006
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00276328
Health Authority:	Tunisia: Office of Pharmacies and Medicines; Morocco: Ministry of Public Health

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on February 09, 2009