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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmectite (Smecta®) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Médical, 50 rue Tata | Casablanca | 20000 | Morocco | |||
| Cabinet Medical, 17 Boulevard Bir Anzaran |
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| % 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) |
| Casablanca |
| 20200 |
| Morocco |
| Cabinet Médical, 12 rue Reaumur | Casablanca | 20200 | Morocco |
| Cabinet Médical, 94 boulevard du 11 janvier | Casablanca | 20200 | Morocco |
| Hopital Ibn Roched | Casablanca | 20200 | Morocco |
| Hôpital Ben Msick Sidi Othmane | Casablanca | 20200 | Morocco |
| Hôpital Avicenne | Rabat | 99 | Morocco |
| Hopital régional de Ben Arous | Ben Arous | 2013 | Tunisia |
| Hôpital des F.S.I. | La Marsa | 2070 | Tunisia |
| Hôpital Régional de Menzel | Menzel Bourguiba | 7050 | Tunisia |
| Hôpital Fattouma Bourguiba | Monastir | 5000 | Tunisia |
| Hôpital Régional | Nabeul | 8000 | Tunisia |
| Hôpital Hédi Chaker | Sfax | 3029 | Tunisia |
| avenue du 20 mars 1956 - Cité Jawhara | Sousse | 4000 | Tunisia |
| Cité Laouina | Sousse | 4000 | Tunisia |
| rue Abou Baker Essadik | Sousse | 4000 | Tunisia |
| rue Alexandre Dumas | Sousse | 4000 | Tunisia |
| rue Sidi Sahloul - Hammam | Sousse | 4011 | Tunisia |
| rue Ali Ibn Taleb - Messadine | Sousse | 4013 | Tunisia |
| Avenue Habib Bourguiba - Kalaa Essghira | Sousse | 4021 | Tunisia |
| Avenue Habib Bourguiba - Sidi Bou Ali | Sousse | 4040 | Tunisia |
| Cité Sahloul, route principale, AFH No.9 | Sousse | 4054 | Tunisia |
| Hôpital Sahloul | Sousse | 4054 | Tunisia |
| rue du 1 er juin - Kalaa Kebira | Sousse | 4060 | Tunisia |
| Polyclinique Taoufik | Tunis | 1002 | Tunisia |
| Rue Micipsa | Tunis | 1002 | Tunisia |
| Hôpital Charles Nicolle | Tunis | 1006 | Tunisia |
| Hôpital La Rabta | Tunis | 1007 | Tunisia |
| Hôpital Habib Thameur | Tunis | 1008 | Tunisia |
| Hôpital Militaire | Tunis | 1008 | Tunisia |
| Polyclinique de la CNSS | Tunis | 1008 | Tunisia |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C033214 | Smectite |
| C016752 | smecta |
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