Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
- Registration Number
- NCT02704091
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 858
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Smecta Smecta 2 sachets, three times a day (TID), during 5 to 9 days Smecta placebo Smecta placebo 2 sachets of placebo, TID, during 5 to 9 days
- Primary Outcome Measures
Name Time Method Time to Recovery From randomisation (Day 1) up to Day 9 Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Associated Symptoms, Per 12-Hour Period From randomisation (Day 1) up to Day 9 Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.
Time From Diarrhoea Onset to Recovery From randomisation (Day 1) up to Day 9 The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Time From Diarrhoea Onset to First Formed Stool From randomisation (Day 1) up to Day 9 The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Time From the First Study Treatment Intake to the Last Watery Stool From randomisation (Day 1) up to Day 9 The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Number of Stools, Per 12-Hour Period From randomisation (Day 1) up to Day 9 Number of stools, per 12-hour period, was recorded in the DEB.
Number of Watery Stools, Per 12-Hour Period From randomisation (Day 1) up to Day 9 Number of watery stools, per 12-hour period, was recorded in the DEB.
Abdominal Pain Intensity Scores, Per 12-Hour Period From randomisation (Day 1) up to Day 9 Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.
Trial Locations
- Locations (61)
CHU BEN BADIS Constantine
🇩🇿Constantine, Algeria
CSB Zouhour
🇹🇳Sousse, Tunisia
Cairo University
🇪🇬Cairo, Egypt
CSB Kalaa Kébira
🇹🇳Sousse, Tunisia
CSB Zaouia
🇹🇳Sousse, Tunisia
Hopital Militaire Principal d'instructions de Tunis
🇹🇳Tunis, Tunisia
Centre de santé de base Ras Tabia
🇹🇳Tunis, Tunisia
Centre de santé de base Ibn Khaldoun
🇹🇳Tunis, Tunisia
Cabinet privé, 29 avenue amara Youcef
🇩🇿Blida, Algeria
Polyclinique DRARIA
🇩🇿Draria, Algeria
EPH EL Afroun
🇩🇿Blida, Algeria
CHU Oran
🇩🇿Oran, Algeria
EPH Bologhine
🇩🇿Bologhine, Algeria
Polyclinique d'el Achour
🇩🇿Algiers, Algeria
CSB Sidi Bou Ali
🇹🇳Sousse, Tunisia
PrzychodniaLekarska ORLIK Sp. z o.o
🇵🇱Warszawa, Poland
Centre de santé de base Bab Laasal
🇹🇳Tunis, Tunisia
Hôpital des Forces de Sécurité Intérieure
🇹🇳La Marsa, Tunisia
CSB Nager
🇹🇳Sousse, Tunisia
CSB Oued Blibène
🇹🇳Sousse, Tunisia
CSB Riadh
🇹🇳Sousse, Tunisia
Centre de santé de base Ksar Said
🇹🇳Tunis, Tunisia
CHU Mustapha
🇩🇿Algiers, Algeria
Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM
🇩🇿Algiers, Algeria
CHU Beni Messous
🇩🇿Algiers, Algeria
Polyclinique de Dély Brahim
🇩🇿Deli Ibrahim, Algeria
Polyclinique de Baba Hassen
🇩🇿Algiers, Algeria
EPH Blida
🇩🇿Blida, Algeria
Cabinet privé, cité des 408 lgmts Bt3
🇩🇿Boumerdas, Algeria
Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova
🇨🇿Kralupy nad Vltavou, Czechia
Ordinace PL pro dospělé
🇨🇿Čáslav, Czechia
MUDr. Alena Břeňová - PL pro dospělé
🇨🇿Pardubice, Czechia
AK Medipraktik, s.r.o
🇨🇿Orlová, Czechia
Ordinace Bělehradská s.r.o
🇨🇿Praha, Czechia
Praktický lékař Radotín, s.r.o.
🇨🇿Radotín, Czechia
Clinical Research Center
🇪🇬Alexandria, Egypt
Ain Shams University Hospitals
🇪🇬Cairo, Egypt
Air Force Specialized Hospital
🇪🇬Cairo, Egypt
Tanta University
🇪🇬Tanta, Egypt
Al Hussein University Hospital
🇪🇬Cairo, Egypt
Badr University Hospital
🇪🇬Cairo, Egypt
Hammoud Hospital University Medical Center
🇱🇧Sidon, Lebanon
Komisji Edukacji Narodowej 3B lok. 1
🇵🇱Białystok, Poland
Cermed
🇵🇱Białystok, Poland
KLIMED
🇵🇱Łomża, 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
🇵🇱Kraków, Poland
Niepubliczny Zakład Opieki Zdrowotnej Ugorek sp. z o.o.
🇵🇱Kraków, Poland
Niepubliczny Zakład Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dąbie" spółka z o.o.
🇵🇱Kraków, Poland
Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spółka z o.o.
🇵🇱Lublin, Poland
NZOZ Primed
🇵🇱Malbork, Poland
Solumed Research Site
🇵🇱Poznań, Poland
Hôpital Régional de Ben Arous
🇹🇳Ben Arous, Tunisia
Centrum Medyczne Pratia S.A
🇵🇱Warsaw, Poland
Centre intermédiaire de Santé de Base
🇹🇳La Marsa, Tunisia
CSB Akouda
🇹🇳Sousse, Tunisia
CSB Hedi Chaker
🇹🇳Sousse, Tunisia
Hôpital Universitaire Salhoul
🇹🇳Sousse, Tunisia
OPL, spol. s r.o.
🇨🇿Hrochův Týnec, Czechia