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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276328
• Other study ID #: 2-31-00250-009
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Diosmectite (Smecta®)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Morocco,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time (hours) from first sachet intake to the last watery stool
Secondary	Number of stools and number of watery stools per 12 hour period
Secondary	% of patients with recovery, per 12 hour period
Secondary	% of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
Secondary	Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)