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

This study has been completed.

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
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 September 05, 2008




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