Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults

Acute Diarrhoea Clinical Trial

— ADIASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704091
• Other study ID #: F-FR-00250-105
• Secondary ID: 2015-001138-10
• Status: Completed
• Phase: Phase 4
• Start date: March 17, 2016
• Est. completion date: April 8, 2019

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Diarrhoea
• Diarrhea

Intervention

Drug:
• Smecta

• Smecta placebo

Locations

Country	Name	City	State
Algeria	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
Czechia	Ordinace PL pro dospelé	Cáslav
Czechia	OPL, spol. s r.o.	Hrochuv Týnec
Czechia	Ordinace PL pro dospelé	Kladno
Czechia	Ordinace PL pro dospelé, Poliklinika prízemí, Nerudova	Kralupy nad Vltavou
Czechia	AK Medipraktik, s.r.o	Orlová
Czechia	MUDr. Alena Brenová - PL pro dospelé	Pardubice
Czechia	Ordinace Belehradská s.r.o	Praha
Czechia	Ordinace PL pro dospelé	Praha 4	Nusle
Czechia	Ordinace PL pro dospelé	Praha 6
Czechia	Ordinace PL pro dospelé	Praha 6, 2.patro
Czechia	Ordinace PL pro dospelé	Praha 8
Czechia	Ordinace PL pro dospelé	Praha 8	Karlín
Czechia	Ordinace PL pro dospelé	Praha 9	Vysocany
Czechia	Praktický lékar Radotín, s.r.o.	Radotín
Czechia	Ordinace PL pro dospelé	Vrchlabi
Egypt	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
Lebanon	Hammoud Hospital University Medical Center	Sidon
Poland	Cermed	Bialystok
Poland	Komisji Edukacji Narodowej 3B lok. 1	Bialystok
Poland	KLIMED	Bychawa
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra	Katowice
Poland	MEKMED S.C. Przychodnia Lekarska NZOZ	Katowice
Poland	Lekarska Spólka Partnerska Familia T S A Gugala	Kozienice
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dabie" spólka z o.o.	Kraków
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Ugorek sp. z o.o.	Kraków
Poland	Praktyka Lekarzy Rodzinnych NZOZ	Kraków
Poland	KLIMED	Lomza
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spólka 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	Warszawa
Tunisia	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 Akouda	Sousse
Tunisia	CSB Hedi Chaker	Sousse
Tunisia	CSB Kalaa Kébira	Sousse
Tunisia	CSB Nager	Sousse
Tunisia	CSB Oued Blibène	Sousse
Tunisia	CSB Riadh	Sousse
Tunisia	CSB Sidi Bou Ali	Sousse
Tunisia	CSB Zaouia	Sousse
Tunisia	CSB Zouhour	Sousse
Tunisia	Hôpital Universitaire Salhoul	Sousse
Tunisia	Centre de santé de base Bab Laasal	Tunis
Tunisia	Centre de santé de base Ibn Khaldoun	Tunis
Tunisia	Centre de santé de base Ksar Said	Tunis
Tunisia	Centre de santé de base Ras Tabia	Tunis
Tunisia	Hopital Militaire Principal d'instructions de Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Algeria,  Czechia,  Egypt,  Lebanon,  Poland,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Recovery	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).	From randomisation (Day 1) up to Day 9
Secondary	Time From Diarrhoea Onset to Recovery	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).	From randomisation (Day 1) up to Day 9
Secondary	Time From Diarrhoea Onset to First Formed Stool	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).	From randomisation (Day 1) up to Day 9
Secondary	Time From the First Study Treatment Intake to the Last Watery Stool	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).	From randomisation (Day 1) up to Day 9
Secondary	Number of Stools, Per 12-Hour Period	Number of stools, per 12-hour period, was recorded in the DEB.	From randomisation (Day 1) up to Day 9
Secondary	Number of Watery Stools, Per 12-Hour Period	Number of watery stools, per 12-hour period, was recorded in the DEB.	From randomisation (Day 1) up to Day 9
Secondary	Percentage of Participants With Associated Symptoms, Per 12-Hour Period	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.	From randomisation (Day 1) up to Day 9
Secondary	Abdominal Pain Intensity Scores, Per 12-Hour Period	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.	From randomisation (Day 1) up to Day 9