Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00276328
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Diosmectite (Smecta®) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.
Study Start Date : January 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea




Primary Outcome Measures :
  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 Outcome Measures :
  1. Time (hours) from first sachet intake to the last watery stool
  2. Number of stools and number of watery stools per 12 hour period
  3. % of patients with recovery, per 12 hour period
  4. % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
  5. Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276328


Locations
Layout table for location information
Morocco
Cabinet Médical, 50 rue Tata
Casablanca, Morocco, 20000
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
Casablanca, Morocco, 20200
Hôpital Avicenne
Rabat, Morocco, 99
Tunisia
Hopital régional de Ben Arous
Ben Arous, Tunisia, 2013
Hôpital des F.S.I.
La Marsa, Tunisia, 2070
Hôpital Régional de Menzel
Menzel Bourguiba, Tunisia, 7050
Hôpital Fattouma Bourguiba
Monastir, Tunisia, 5000
Hôpital Régional
Nabeul, Tunisia, 8000
Hôpital Hédi Chaker
Sfax, Tunisia, 3029
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, 4000
rue Sidi Sahloul - Hammam
Sousse, Tunisia, 4011
rue Ali Ibn Taleb - Messadine
Sousse, Tunisia, 4013
Avenue Habib Bourguiba - Kalaa Essghira
Sousse, Tunisia, 4021
Avenue Habib Bourguiba - Sidi Bou Ali
Sousse, Tunisia, 4040
Cité Sahloul, route principale, AFH No.9
Sousse, Tunisia, 4054
Hôpital Sahloul
Sousse, Tunisia, 4054
rue du 1 er juin - Kalaa Kebira
Sousse, Tunisia, 4060
Polyclinique Taoufik
Tunis, Tunisia, 1002
Rue Micipsa
Tunis, Tunisia, 1002
Hôpital Charles Nicolle
Tunis, Tunisia, 1006
Hôpital La Rabta
Tunis, Tunisia, 1007
Hôpital Habib Thameur
Tunis, Tunisia, 1008
Hôpital Militaire
Tunis, Tunisia, 1008
Polyclinique de la CNSS
Tunis, Tunisia, 1008
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00276328     History of Changes
Other Study ID Numbers: 2-31-00250-009
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms