Status:

COMPLETED

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

Lead Sponsor:

Ipsen

Conditions:

Diarrhea

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2006

Estimated Enrollment :

346 Patients enrolled

Trial Details

Trial ID

NCT00276328

Start Date

January 1 2005

End Date

July 1 2006

Last Update

April 28 2020

Active Locations (31)

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Page 1 of 8 (31 locations)

1

Cabinet Médical, 50 rue Tata

Casablanca, Morocco, 20000

2

Cabinet Medical, 17 Boulevard Bir Anzaran

Casablanca, Morocco, 20200

3

Cabinet Médical, 12 rue Reaumur

Casablanca, Morocco, 20200

4

Cabinet Médical, 94 boulevard du 11 janvier

Casablanca, Morocco, 20200