Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
NCT ID: NCT02704091
Last Updated: 2020-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
858 participants
INTERVENTIONAL
2016-03-17
2019-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Smecta
2 sachets, three times a day (TID), during 5 to 9 days
Smecta
Smecta placebo
2 sachets of placebo, TID, during 5 to 9 days
Smecta placebo
Interventions
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Smecta
Smecta placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subject (outpatient) legally considered as an adult (age of majority). In Czech Republic, the upper limit of age will be 70 years inclusive. In Egypt, the upper limit of age will be 60 years inclusive.
* Subject has a diagnosis of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day within the last 48 hours without associated alarm symptoms
* Subject has, usually, normal bowel habits (Rome III criteria), i.e. at least 3 stools per week and no more than 3 stools per day
* Subject must be willing and able to comply with study restrictions and willing to return to the clinic for the follow up evaluation(s) as specified in the protocol.
Exclusion Criteria
* Bloody diarrhoea\*,
* pus in the stools\*,
* fever ≥38°C\*,
* moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration\*,
* repeated vomiting\*,
* persistent abdominal pain\* \*These symptoms are considered as alarm symptoms
* other episode of acute watery diarrhoea within the previous 30 days,
* persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more than 14 days,
* history of chronic diarrhoea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months,
* traveller's diarrhoea defined as a diarrhoeal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhoea episode, occurring usually within the first 2 weeks of the stay in a foreign environment.
* Diarrhoea suspected to be induced by drug for example:
* antibiotic therapy, including Clostridium difficile-induced diarrhoea, within 1 week before entry in the study,
* laxative agent
* thyroid hormone (at a nonstabilised dosing),
* intake of other prohibited drugs (as specified in the protocol)
* anti-diarrhoeal agent intake during the last month,
* any subject requiring repeated intake of a drug with a narrow therapeutic margin (as specified in the protocol),
* history of hypersensitivity to diosmectite or its excipients or placebo components,
* subject likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agent, anti-diarrhoeal agent, antiemetic drug, antispasmodic drug),
* use of any investigational medication within the last 30 days before entering this study,
* subject who previously entered in a clinical study within the past 30 days.
* History of gastric or intestinal resection, vagotomy,
* known digestive malabsorption disease, including coeliac disease
* known lactose intolerance,
* any suspicion of abdominal surgery need,
* known inflammatory bowel disease.
* Known Human immunodeficiency virus (HIV) positive status,
* known or suspected immunosuppression,
* known severe renal insufficiency (including e-GFR not less than 45 mL/min) or hepatic insufficiency,
* known endocrine disease or Type II Diabetes Mellitus with HBA1c more than 8,5% or insulin-dependent diabetes,
* history of, or known current, problems with alcohol abuse and/or known drug addiction (cocaine, heroin, hashish…),
* previous enrolment in this study,
* any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM
Algiers, , Algeria
CHU Beni Messous
Algiers, , Algeria
CHU Mustapha
Algiers, , Algeria
Polyclinique d'el Achour
Algiers, , Algeria
Polyclinique de Baba Hassen
Algiers, , Algeria
Cabinet privé, 29 avenue amara Youcef
Blida, , Algeria
EPH Blida
Blida, , Algeria
EPH EL Afroun
Blida, , Algeria
EPH Bologhine
Bologhine, , Algeria
Cabinet privé, cité des 408 lgmts Bt3
Boumerdas, , Algeria
CHU BEN BADIS Constantine
Constantine, , Algeria
Polyclinique de Dély Brahim
Deli Ibrahim, , Algeria
Polyclinique DRARIA
Draria, , Algeria
CHU Oran
Oran, , Algeria
Ordinace PL pro dospělé
Prague, Karlín, Czechia
Ordinace PL pro dospělé
Prague, Nusle, Czechia
Ordinace PL pro dospělé
Prague, Vysočany, Czechia
Ordinace PL pro dospělé
Čáslav, , Czechia
OPL, spol. s r.o.
Hrochův Týnec, , Czechia
Ordinace PL pro dospělé
Kladno, , Czechia
Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova
Kralupy nad Vltavou, , Czechia
AK Medipraktik, s.r.o
Orlová, , Czechia
MUDr. Alena Břeňová - PL pro dospělé
Pardubice, , Czechia
Ordinace Bělehradská s.r.o
Prague, , Czechia
Ordinace PL pro dospělé
Prague, , Czechia
Ordinace PL pro dospělé
Prague, , Czechia
Ordinace PL pro dospělé
Praha 6, 2.patro, , Czechia
Praktický lékař Radotín, s.r.o.
Radotín, , Czechia
Ordinace PL pro dospělé
Vrchlabí, , Czechia
Clinical Research Center
Alexandria, , Egypt
Ain Shams University Hospitals
Cairo, , Egypt
Air Force Specialized Hospital
Cairo, , Egypt
Al Hussein University Hospital
Cairo, , Egypt
Badr University Hospital
Cairo, , Egypt
Cairo University
Cairo, , Egypt
Tanta University
Tanta, , Egypt
Hammoud Hospital University Medical Center
Sidon, , Lebanon
Komisji Edukacji Narodowej 3B lok. 1
Bialystok, , Poland
Cermed
Bialystok, , Poland
KLIMED
Bychawa, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
Katowice, , Poland
MEKMED S.C. Przychodnia Lekarska NZOZ
Katowice, , Poland
Lekarska Spółka Partnerska Familia T S A Gugała
Kozienice, , Poland
Praktyka Lekarzy Rodzinnych NZOZ
Krakow, , Poland
Niepubliczny Zakład Opieki Zdrowotnej Ugorek sp. z o.o.
Krakow, , Poland
Niepubliczny Zakład Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dąbie" spółka z o.o.
Krakow, , Poland
Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spółka z o.o.
Lublin, , Poland
NZOZ Primed
Malbork, , Poland
Solumed Research Site
Poznan, , Poland
Centrum Medyczne Pratia S.A
Warsaw, , Poland
PrzychodniaLekarska ORLIK Sp. z o.o
Warsaw, , Poland
KLIMED
Łomża, , Poland
CSB Zouhour
Ben Arous, , Tunisia
Hôpital Régional de Ben Arous
Ben Arous, , Tunisia
Centre intermédiaire de Santé de Base
La Marsa, , Tunisia
Hôpital des Forces de Sécurité Intérieure
La Marsa, , Tunisia
CSB Hedi Chaker
Sousse, , Tunisia
Hôpital Universitaire Salhoul
Sousse, , Tunisia
CSB Akouda
Sousse, , Tunisia
CSB Sidi Bou Ali
Sousse, , Tunisia
CSB Zouhour
Sousse, , Tunisia
CSB Nager
Sousse, , Tunisia
CSB Riadh
Sousse, , Tunisia
CSB Oued Blibène
Sousse, , Tunisia
CSB Kalaa Kébira
Sousse, , Tunisia
CSB Zaouia
Sousse, , Tunisia
Centre de santé de base Bab Laasal
Tunis, , Tunisia
Hopital Militaire Principal d'instructions de Tunis
Tunis, , Tunisia
Centre de santé de base Ras Tabia
Tunis, , Tunisia
Centre de santé de base Ksar Said
Tunis, , Tunisia
Centre de santé de base Ibn Khaldoun
Tunis, , Tunisia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001138-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F-FR-00250-105
Identifier Type: -
Identifier Source: org_study_id