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

Primary Purpose

Diarrhea

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Diosmectite (Smecta®)
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet Médical, 50 rue Tata
  • Cabinet Medical, 17 Boulevard Bir Anzaran
  • Cabinet Médical, 12 rue Reaumur
  • Cabinet Médical, 94 boulevard du 11 janvier
  • Hopital Ibn Roched
  • Hôpital Ben Msick Sidi Othmane
  • Hôpital Avicenne
  • Hopital régional de Ben Arous
  • Hôpital des F.S.I.
  • Hôpital Régional de Menzel
  • Hôpital Fattouma Bourguiba
  • Hôpital Régional
  • Hôpital Hédi Chaker
  • avenue du 20 mars 1956 - Cité Jawhara
  • Cité Laouina
  • rue Abou Baker Essadik
  • rue Alexandre Dumas
  • rue Sidi Sahloul - Hammam
  • rue Ali Ibn Taleb - Messadine
  • Avenue Habib Bourguiba - Kalaa Essghira
  • Avenue Habib Bourguiba - Sidi Bou Ali
  • Cité Sahloul, route principale, AFH No.9
  • Hôpital Sahloul
  • rue du 1 er juin - Kalaa Kebira
  • Polyclinique Taoufik
  • Rue Micipsa
  • Hôpital Charles Nicolle
  • Hôpital La Rabta
  • Hôpital Habib Thameur
  • Hôpital Militaire
  • Polyclinique de la CNSS

Outcomes

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)

Full Information

First Posted
January 12, 2006
Last Updated
April 27, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00276328
Brief Title
Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Diosmectite (Smecta®)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time (hours) from first sachet intake to the last watery stool
Title
Number of stools and number of watery stools per 12 hour period
Title
% of patients with recovery, per 12 hour period
Title
% of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
Title
Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Cabinet Médical, 50 rue Tata
City
Casablanca
ZIP/Postal Code
20000
Country
Morocco
Facility Name
Cabinet Medical, 17 Boulevard Bir Anzaran
City
Casablanca
ZIP/Postal Code
20200
Country
Morocco
Facility Name
Cabinet Médical, 12 rue Reaumur
City
Casablanca
ZIP/Postal Code
20200
Country
Morocco
Facility Name
Cabinet Médical, 94 boulevard du 11 janvier
City
Casablanca
ZIP/Postal Code
20200
Country
Morocco
Facility Name
Hopital Ibn Roched
City
Casablanca
ZIP/Postal Code
20200
Country
Morocco
Facility Name
Hôpital Ben Msick Sidi Othmane
City
Casablanca
ZIP/Postal Code
20200
Country
Morocco
Facility Name
Hôpital Avicenne
City
Rabat
ZIP/Postal Code
99
Country
Morocco
Facility Name
Hopital régional de Ben Arous
City
Ben Arous
ZIP/Postal Code
2013
Country
Tunisia
Facility Name
Hôpital des F.S.I.
City
La Marsa
ZIP/Postal Code
2070
Country
Tunisia
Facility Name
Hôpital Régional de Menzel
City
Menzel Bourguiba
ZIP/Postal Code
7050
Country
Tunisia
Facility Name
Hôpital Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Hôpital Régional
City
Nabeul
ZIP/Postal Code
8000
Country
Tunisia
Facility Name
Hôpital Hédi Chaker
City
Sfax
ZIP/Postal Code
3029
Country
Tunisia
Facility Name
avenue du 20 mars 1956 - Cité Jawhara
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Cité Laouina
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
rue Abou Baker Essadik
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
rue Alexandre Dumas
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
rue Sidi Sahloul - Hammam
City
Sousse
ZIP/Postal Code
4011
Country
Tunisia
Facility Name
rue Ali Ibn Taleb - Messadine
City
Sousse
ZIP/Postal Code
4013
Country
Tunisia
Facility Name
Avenue Habib Bourguiba - Kalaa Essghira
City
Sousse
ZIP/Postal Code
4021
Country
Tunisia
Facility Name
Avenue Habib Bourguiba - Sidi Bou Ali
City
Sousse
ZIP/Postal Code
4040
Country
Tunisia
Facility Name
Cité Sahloul, route principale, AFH No.9
City
Sousse
ZIP/Postal Code
4054
Country
Tunisia
Facility Name
Hôpital Sahloul
City
Sousse
ZIP/Postal Code
4054
Country
Tunisia
Facility Name
rue du 1 er juin - Kalaa Kebira
City
Sousse
ZIP/Postal Code
4060
Country
Tunisia
Facility Name
Polyclinique Taoufik
City
Tunis
ZIP/Postal Code
1002
Country
Tunisia
Facility Name
Rue Micipsa
City
Tunis
ZIP/Postal Code
1002
Country
Tunisia
Facility Name
Hôpital Charles Nicolle
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
Hôpital La Rabta
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Hôpital Habib Thameur
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Hôpital Militaire
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Polyclinique de la CNSS
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia

12. IPD Sharing Statement

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

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