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

Tracking Information

First Received Date ^ICMJE

January 12, 2006

Last Updated Date

January 16, 2007

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00276328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diarrhea

Intervention ^ICMJE

Drug: Diosmectite (Smecta®)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

280

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Morocco, Tunisia

Administrative Information

NCT ID ^ICMJE

NCT00276328

Responsible Party

Study ID Numbers ^ICMJE

2-31-00250-009

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Philippe Garnier, MD

Ipsen

Information Provided By

Ipsen

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP