Clinical trial NCT00276328: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: 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 outcomes:
measure: Time (hours) from first sachet intake to the last watery stool
measure: Number of stools and number of watery stools per 12 hour period
measure: % of patients with recovery, per 12 hour period
measure: % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
measure: Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)
Other outcomes:
Locations:
city: Casablanca
country: Morocco
facility: Cabinet Médical, 50 rue Tata
city: Casablanca
country: Morocco
facility: Cabinet Medical, 17 Boulevard Bir Anzaran
city: Casablanca
country: Morocco
facility: Cabinet Médical, 12 rue Reaumur
city: Casablanca
country: Morocco
facility: Cabinet Médical, 94 boulevard du 11 janvier
city: Casablanca
country: Morocco
facility: Hopital Ibn Roched
city: Casablanca
country: Morocco
facility: Hôpital Ben Msick Sidi Othmane
city: Rabat
country: Morocco
facility: Hôpital Avicenne
city: Ben Arous
country: Tunisia
facility: Hopital régional de Ben Arous
city: La Marsa
country: Tunisia
facility: Hôpital des F.S.I.
city: Menzel Bourguiba
country: Tunisia
facility: Hôpital Régional de Menzel
city: Monastir
country: Tunisia
facility: Hôpital Fattouma Bourguiba
city: Nabeul
country: Tunisia
facility: Hôpital Régional
city: Sfax
country: Tunisia
facility: Hôpital Hédi Chaker
city: Sousse
country: Tunisia
facility: avenue du 20 mars 1956 - Cité Jawhara
city: Sousse
country: Tunisia
facility: Cité Laouina
city: Sousse
country: Tunisia
facility: rue Abou Baker Essadik
city: Sousse
country: Tunisia
facility: rue Alexandre Dumas
city: Sousse
country: Tunisia
facility: rue Sidi Sahloul - Hammam
city: Sousse
country: Tunisia
facility: rue Ali Ibn Taleb - Messadine
city: Sousse
country: Tunisia
facility: Avenue Habib Bourguiba - Kalaa Essghira
city: Sousse
country: Tunisia
facility: Avenue Habib Bourguiba - Sidi Bou Ali
city: Sousse
country: Tunisia
facility: Cité Sahloul, route principale, AFH No.9
city: Sousse
country: Tunisia
facility: Hôpital Sahloul
city: Sousse
country: Tunisia
facility: rue du 1 er juin - Kalaa Kebira
city: Tunis
country: Tunisia
facility: Polyclinique Taoufik
city: Tunis
country: Tunisia
facility: Rue Micipsa
city: Tunis
country: Tunisia
facility: Hôpital Charles Nicolle
city: Tunis
country: Tunisia
facility: Hôpital La Rabta
city: Tunis
country: Tunisia
facility: Hôpital Habib Thameur
city: Tunis
country: Tunisia
facility: Hôpital Militaire
city: Tunis
country: Tunisia
facility: Polyclinique de la CNSS
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: