Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults
- Conditions
- Diarrhea
- Registration Number
- NCT00276328
- Lead Sponsor
- Ipsen
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 346
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of stools and number of watery stools 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) Time (hours) from first sachet intake to the last watery stool % of patients with recovery, per 12 hour period % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
Trial Locations
- Locations (31)
Cité Laouina
🇹🇳Sousse, Tunisia
rue Sidi Sahloul - Hammam
🇹🇳Sousse, Tunisia
Hôpital des F.S.I.
🇹🇳La Marsa, Tunisia
Cabinet Médical, 50 rue Tata
🇲🇦Casablanca, Morocco
Hôpital Ben Msick Sidi Othmane
🇲🇦Casablanca, Morocco
Cabinet Médical, 94 boulevard du 11 janvier
🇲🇦Casablanca, Morocco
Cabinet Medical, 17 Boulevard Bir Anzaran
🇲🇦Casablanca, Morocco
Hôpital Avicenne
🇲🇦Rabat, Morocco
Avenue Habib Bourguiba - Kalaa Essghira
🇹🇳Sousse, Tunisia
Cité Sahloul, route principale, AFH No.9
🇹🇳Sousse, Tunisia
Cabinet Médical, 12 rue Reaumur
🇲🇦Casablanca, Morocco
Hopital Ibn Roched
🇲🇦Casablanca, Morocco
Hopital régional de Ben Arous
🇹🇳Ben Arous, Tunisia
Hôpital Régional de Menzel
🇹🇳Menzel Bourguiba, Tunisia
Hôpital Fattouma Bourguiba
🇹🇳Monastir, Tunisia
Hôpital Régional
🇹🇳Nabeul, Tunisia
avenue du 20 mars 1956 - Cité Jawhara
🇹🇳Sousse, Tunisia
rue Alexandre Dumas
🇹🇳Sousse, Tunisia
Avenue Habib Bourguiba - Sidi Bou Ali
🇹🇳Sousse, Tunisia
Hôpital Hédi Chaker
🇹🇳Sfax, Tunisia
rue Abou Baker Essadik
🇹🇳Sousse, Tunisia
Rue Micipsa
🇹🇳Tunis, Tunisia
Hôpital Habib Thameur
🇹🇳Tunis, Tunisia
rue Ali Ibn Taleb - Messadine
🇹🇳Sousse, Tunisia
Hôpital Sahloul
🇹🇳Sousse, Tunisia
rue du 1 er juin - Kalaa Kebira
🇹🇳Sousse, Tunisia
Polyclinique Taoufik
🇹🇳Tunis, Tunisia
Hôpital La Rabta
🇹🇳Tunis, Tunisia
Hôpital Militaire
🇹🇳Tunis, Tunisia
Polyclinique de la CNSS
🇹🇳Tunis, Tunisia
Hôpital Charles Nicolle
🇹🇳Tunis, Tunisia