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

NCT02704091 | Completed Phase 4 Results

• 2 other identifiers: F-FR-00250-1052015-001138-10
• Study Type: interventional
• Target: 858
• Locations: 6 countries
• Sites: 71

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.

Conditions

Acute Diarrhoea

Outcome Measures

Primary Outcomes (1)

• 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 Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB.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 Outcomes (7)

• Time From Diarrhoea Onset to Recovery

  From randomisation (Day 1) up to Day 9

• Time From Diarrhoea Onset to First Formed Stool

  From randomisation (Day 1) up to Day 9

• Time From the First Study Treatment Intake to the Last Watery Stool

  From randomisation (Day 1) up to Day 9

• Number of Stools, Per 12-Hour Period

  From randomisation (Day 1) up to Day 9

• Number of Watery Stools, Per 12-Hour Period

  From randomisation (Day 1) up to Day 9

Study Arms (2)

Smecta

ACTIVE COMPARATOR

2 sachets, three times a day (TID), during 5 to 9 days

Drug: Smecta

Smecta placebo

PLACEBO COMPARATOR

2 sachets of placebo, TID, during 5 to 9 days

Drug: Smecta placebo

Interventions

Smecta DRUG

Also known as: Diosmectite Beaufour

Smecta

Smecta placebo DRUG

Smecta placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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),

Sponsors & Collaborators

• Ipsen: lead

Study Sites (71)

Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM

Algiers, 16000, Algeria

Location

CHU Beni Messous

Algiers, 16000, Algeria

Location

CHU Mustapha

Algiers, 16000, Algeria

Location

Polyclinique d'el Achour

Algiers, 16000, Algeria

Location

Polyclinique de Baba Hassen

Algiers, 16000, Algeria

Location

Cabinet privé, 29 avenue amara Youcef

Blida, 09000, Algeria

Location

EPH Blida

Blida, 09000, Algeria

Location

EPH EL Afroun

Blida, 09000, Algeria

Location

EPH Bologhine

Bologhine, 16000, Algeria

Location

Cabinet privé, cité des 408 lgmts Bt3

Boumerdas, 35000, Algeria

Location

CHU BEN BADIS Constantine

Constantine, 25000, Algeria

Location

Polyclinique de Dély Brahim

Deli Ibrahim, 16000, Algeria

Location

Polyclinique DRARIA

Draria, 16000, Algeria

Location

CHU Oran

Oran, 31000, Algeria

Location

Ordinace PL pro dospělé

Prague, Karlín, 186 00, Czechia

Location

Ordinace PL pro dospělé

Prague, Nusle, 140 000, Czechia

Location

Ordinace PL pro dospělé

Prague, Vysočany, 190 00, Czechia

Location

Ordinace PL pro dospělé

Čáslav, 286 01, Czechia

Location

OPL, spol. s r.o.

Hrochův Týnec, 53862, Czechia

Location

Ordinace PL pro dospělé

Kladno, 27201, Czechia

Location

Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova

Kralupy nad Vltavou, 278 01, Czechia

Location

AK Medipraktik, s.r.o

Orlová, 73514, Czechia

Location

MUDr. Alena Břeňová - PL pro dospělé

Pardubice, 53009, Czechia

Location

Ordinace Bělehradská s.r.o

Prague, 12000, Czechia

Location

Ordinace PL pro dospělé

Prague, 164 00, Czechia

Location

Ordinace PL pro dospělé

Prague, 182 00, Czechia

Location

Ordinace PL pro dospělé

Praha 6, 2.patro, 160 00, Czechia

Location

Praktický lékař Radotín, s.r.o.

Radotín, 15300, Czechia

Location

Ordinace PL pro dospělé

Vrchlabí, 54301, Czechia

Location

Clinical Research Center

Alexandria, Egypt

Location

Ain Shams University Hospitals

Cairo, Egypt

Location

Air Force Specialized Hospital

Cairo, Egypt

Location

Al Hussein University Hospital

Cairo, Egypt

Location

Badr University Hospital

Cairo, Egypt

Location

Cairo University

Cairo, Egypt

Location

Tanta University

Tanta, Egypt

Location

Hammoud Hospital University Medical Center

Sidon, Lebanon

Location

Komisji Edukacji Narodowej 3B lok. 1

Bialystok, 15-687, Poland

Location

Cermed

Bialystok, 15270, Poland

Location

KLIMED

Bychawa, 23100, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra

Katowice, 40-018, Poland

Location

MEKMED S.C. Przychodnia Lekarska NZOZ

Katowice, 40-709, Poland

Location

Lekarska Spółka Partnerska Familia T S A Gugała

Kozienice, 26900, Poland

Location

Praktyka Lekarzy Rodzinnych NZOZ

Krakow, 30-664, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Ugorek sp. z o.o.

Krakow, 31455, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Centrum Zdrowia i Profilaktyki "Dąbie" spółka z o.o.

Krakow, 31567, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Praktyka Lekarza Rodzinnego "Eskulap" spółka z o.o.

Lublin, 20-044, Poland

Location

NZOZ Primed

Malbork, 82-200, Poland

Location

Solumed Research Site

Poznan, 60529, Poland

Location

Centrum Medyczne Pratia S.A

Warsaw, 01868, Poland

Location

PrzychodniaLekarska ORLIK Sp. z o.o

Warsaw, 04-041, Poland

Location

KLIMED

Łomża, 18404, Poland

Location

CSB Zouhour

Ben Arous, 41200, Tunisia

Location

Hôpital Régional de Ben Arous

Ben Arous, Tunisia

Location

Centre intermédiaire de Santé de Base

La Marsa, 2078, Tunisia

Location

Hôpital des Forces de Sécurité Intérieure

La Marsa, 2078, Tunisia

Location

CSB Hedi Chaker

Sousse, 4000, Tunisia

Location

Hôpital Universitaire Salhoul

Sousse, 4011, Tunisia

Location

CSB Akouda

Sousse, 4022, Tunisia

Location

CSB Sidi Bou Ali

Sousse, 4022, Tunisia

Location

CSB Zouhour

Sousse, 4031, Tunisia

Location

CSB Nager

Sousse, 4041, Tunisia

Location

CSB Riadh

Sousse, 4041, Tunisia

Location

CSB Oued Blibène

Sousse, 4051, Tunisia

Location

CSB Kalaa Kébira

Sousse, 4060, Tunisia

Location

CSB Zaouia

Sousse, 4081, Tunisia

Location

Centre de santé de base Bab Laasal

Tunis, 1006, Tunisia

Location

Hopital Militaire Principal d'instructions de Tunis

Tunis, 1008, Tunisia

Location

Centre de santé de base Ras Tabia

Tunis, 2000, Tunisia

Location

Centre de santé de base Ksar Said

Tunis, 2009, Tunisia

Location

Centre de santé de base Ibn Khaldoun

Tunis, 2062, Tunisia

Location

MeSH Terms

Interventions

smecta

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen Pharma SAS

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: March 17, 2016
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: November 5, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-11

Locations

PL (15); EG (7); LE (1); TU (19); AL (14); CZ (15)