Clinical trial NCT02704091: Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
Official title: Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomized, Double Blind Placebo Controlled, Parallel, Groups Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Diarrhoea
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent prior to any study related procedures
* 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 related to the acute diarrhoea episode:

* At least one of the following alarm symptoms

  * 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.

Exclusion criteria related to drugs:

* 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.

Other digestive exclusion criteria:

* 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.

Other exclusion criteria:

* 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

Primary outcomes:
measure: Time to Recovery
timeFrame: From randomisation (Day 1) up to Day 9
Secondary outcomes:
measure: Time From Diarrhoea Onset to Recovery
timeFrame: From randomisation (Day 1) up to Day 9
measure: Time From Diarrhoea Onset to First Formed Stool
timeFrame: From randomisation (Day 1) up to Day 9
measure: Time From the First Study Treatment Intake to the Last Watery Stool
timeFrame: From randomisation (Day 1) up to Day 9
measure: Number of Stools, Per 12-Hour Period
timeFrame: From randomisation (Day 1) up to Day 9
measure: Number of Watery Stools, Per 12-Hour Period
timeFrame: From randomisation (Day 1) up to Day 9
measure: Percentage of Participants With Associated Symptoms, Per 12-Hour Period
timeFrame: From randomisation (Day 1) up to Day 9
measure: Abdominal Pain Intensity Scores, Per 12-Hour Period
timeFrame: From randomisation (Day 1) up to Day 9
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM
city: Algiers
country: Algeria
facility: CHU Beni Messous
city: Algiers
country: Algeria
facility: CHU Mustapha
city: Algiers
country: Algeria
facility: Polyclinique d'el Achour
city: Algiers
country: Algeria
facility: Polyclinique de Baba Hassen
city: Blida
country: Algeria
facility: Cabinet privé, 29 avenue amara Youcef
city: Blida
country: Algeria
facility: EPH Blida
city: Blida
country: Algeria
facility: EPH EL Afroun
city: Bologhine
country: Algeria
facility: EPH Bologhine
city: Boumerdas
country: Algeria
facility: Cabinet privé, cité des 408 lgmts Bt3
city: Constantine
country: Algeria
facility: CHU BEN BADIS Constantine
city: Deli Ibrahim
country: Algeria
facility: Polyclinique de Dély Brahim
city: Draria
country: Algeria
facility: Polyclinique DRARIA
city: Oran
country: Algeria
facility: CHU Oran
city: Praha 8
country: Czechia
facility: Ordinace PL pro dospělé
state: Karlín
city: Praha 4
country: Czechia
facility: Ordinace PL pro dospělé
state: Nusle
city: Praha 9
country: Czechia
facility: Ordinace PL pro dospělé
state: Vysočany
city: Hrochův Týnec
country: Czechia
facility: OPL, spol. s r.o.
city: Kladno
country: Czechia
facility: Ordinace PL pro dospělé
city: Kralupy nad Vltavou
country: Czechia
facility: Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova
city: Orlová
country: Czechia
facility: AK Medipraktik, s.r.o
city: Pardubice
country: Czechia
facility: MUDr. Alena Břeňová - PL pro dospělé
city: Praha 6, 2.patro
country: Czechia
facility: Ordinace PL pro dospělé
city: Praha 6
country: Czechia
facility: Ordinace PL pro dospělé
city: Praha 8
country: Czechia
facility: Ordinace PL pro dospělé
city: Praha
country: Czechia
facility: Ordinace Bělehradská s.r.o
city: Radotín
country: Czechia
facility: Praktický lékař Radotín, s.r.o.
city: Vrchlabi
country: Czechia
facility: Ordinace PL pro dospělé
city: Čáslav
country: Czechia
facility: Ordinace PL pro dospělé
city: Alexandria
country: Egypt
facility: Clinical Research Center
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
city: Cairo
country: Egypt
facility: Air Force Specialized Hospital
city: Cairo
country: Egypt
facility: Al Hussein University Hospital
city: Cairo
country: Egypt
facility: Badr University Hospital
city: Cairo
country: Egypt
facility: Cairo University
city: Tanta
country: Egypt
facility: Tanta University
city: Sidon
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Białystok
country: Poland
facility: Komisji Edukacji Narodowej 3B lok. 1
city: Białystok
country: Poland
facility: Cermed
city: Bychawa
country: Poland
facility: KLIMED
city: Katowice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
city: Katowice
country: Poland
facility: MEKMED S.C. Przychodnia Lekarska NZOZ
city: Kozienice
country: Poland
facility: Lekarska Spółka Partnerska Familia T S A Gugała
city: Kraków
country: Poland
facility: Praktyka Lekarzy Rodzinnych NZOZ
city: Kraków
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Ugorek sp. z o.o.
city: Kraków
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dąbie" spółka z o.o.
city: Lublin
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spółka z o.o.
city: Malbork
country: Poland
facility: NZOZ Primed
city: Poznań
country: Poland
facility: Solumed Research Site
city: Warsaw
country: Poland
facility: Centrum Medyczne Pratia S.A
city: Warszawa
country: Poland
facility: PrzychodniaLekarska ORLIK Sp. z o.o
city: Łomża
country: Poland
facility: KLIMED
city: Ben Arous
country: Tunisia
facility: CSB Zouhour
city: Ben Arous
country: Tunisia
facility: Hôpital Régional de Ben Arous
city: La Marsa
country: Tunisia
facility: Centre intermédiaire de Santé de Base
city: La Marsa
country: Tunisia
facility: Hôpital des Forces de Sécurité Intérieure
city: Sousse
country: Tunisia
facility: CSB Hedi Chaker
city: Sousse
country: Tunisia
facility: Hôpital Universitaire Salhoul
city: Sousse
country: Tunisia
facility: CSB Akouda
city: Sousse
country: Tunisia
facility: CSB Sidi Bou Ali
city: Sousse
country: Tunisia
facility: CSB Zouhour
city: Sousse
country: Tunisia
facility: CSB Nager
city: Sousse
country: Tunisia
facility: CSB Riadh
city: Sousse
country: Tunisia
facility: CSB Oued Blibène
city: Sousse
country: Tunisia
facility: CSB Kalaa Kébira
city: Sousse
country: Tunisia
facility: CSB Zaouia
city: Tunis
country: Tunisia
facility: Centre de santé de base Bab Laasal
city: Tunis
country: Tunisia
facility: Hopital Militaire Principal d'instructions de Tunis
city: Tunis
country: Tunisia
facility: Centre de santé de base Ras Tabia
city: Tunis
country: Tunisia
facility: Centre de santé de base Ksar Said
city: Tunis
country: Tunisia
facility: Centre de santé de base Ibn Khaldoun
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: