AzTrials
AzTrials

Acute DiarrhoeaPhase 4ADIASENCT02704091

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

A Phase 4 study testing Smecta in people with Acute Diarrhoea, run by Ipsen at 71 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Diarrhoea
What is being tested?
Smecta
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
858 participants
Where
71 sitesin 6 countries
Study dates
17 Mar 2016to 8 Apr 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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*,
Show all 37Show fewer
  • 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.
  • 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

Trial locations and contacts

71 sites in 6 countries.

71 sites in 6 countries

Tunisia19 sites

  • CSB Zouhour

    Ben Arous, 41200

  • Hôpital Régional de Ben Arous

    Ben Arous

  • Centre intermédiaire de Santé de Base

    La Marsa, 2078

  • Hôpital des Forces de Sécurité Intérieure

    La Marsa, 2078

  • CSB Hedi Chaker

    Sousse, 4000

  • Hôpital Universitaire Salhoul

    Sousse, 4011

  • CSB Akouda

    Sousse, 4022

  • CSB Sidi Bou Ali

    Sousse, 4022

  • CSB Zouhour

    Sousse, 4031

  • CSB Nager

    Sousse, 4041

  • CSB Riadh

    Sousse, 4041

  • CSB Oued Blibène

    Sousse, 4051

  • CSB Kalaa Kébira

    Sousse, 4060

  • CSB Zaouia

    Sousse, 4081

  • Centre de santé de base Bab Laasal

    Tunis, 1006

  • Hopital Militaire Principal d'instructions de Tunis

    Tunis, 1008

  • Centre de santé de base Ras Tabia

    Tunis, 2000

  • Centre de santé de base Ksar Said

    Tunis, 2009

  • Centre de santé de base Ibn Khaldoun

    Tunis, 2062

Other trials in Tunisia

Czechia15 sites

  • Ordinace PL pro dospělé

    Čáslav, 286 01

  • OPL, spol. s r.o.

    Hrochův Týnec, 53862

  • Ordinace PL pro dospělé

    Kladno, 27201

  • Ordinace PL pro dospělé, Poliklinika přízemí, Nerudova

    Kralupy nad Vltavou, 278 01

  • AK Medipraktik, s.r.o

    Orlová, 73514

  • MUDr. Alena Břeňová - PL pro dospělé

    Pardubice, 53009

  • Ordinace PL pro dospělé

    Prague, Karlín, 186 00

  • Ordinace PL pro dospělé

    Prague, Nusle, 140 000

  • Ordinace PL pro dospělé

    Prague, Vysočany, 190 00

  • Ordinace Bělehradská s.r.o

    Prague, 12000

  • Ordinace PL pro dospělé

    Prague, 164 00

  • Ordinace PL pro dospělé

    Prague, 182 00

  • Ordinace PL pro dospělé

    Praha 6, 2.patro, 160 00

  • Praktický lékař Radotín, s.r.o.

    Radotín, 15300

  • Ordinace PL pro dospělé

    Vrchlabí, 54301

Other trials in Czechia

Poland15 sites

  • Komisji Edukacji Narodowej 3B lok. 1

    Bialystok, 15-687

  • Cermed

    Bialystok, 15270

  • KLIMED

    Bychawa, 23100

  • Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra

    Katowice, 40-018

  • MEKMED S.C. Przychodnia Lekarska NZOZ

    Katowice, 40-709

  • Lekarska Spółka Partnerska Familia T S A Gugała

    Kozienice, 26900

  • Praktyka Lekarzy Rodzinnych NZOZ

    Krakow, 30-664

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

    Krakow, 31455

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

    Krakow, 31567

  • KLIMED

    Łomża, 18404

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

    Lublin, 20-044

  • NZOZ Primed

    Malbork, 82-200

  • Solumed Research Site

    Poznan, 60529

  • Centrum Medyczne Pratia S.A

    Warsaw, 01868

  • PrzychodniaLekarska ORLIK Sp. z o.o

    Warsaw, 04-041

Other trials in Poland

Algeria14 sites

  • Cabinet privé, Coopératives El MOSTAKBAL, BIRKHADEM

    Algiers, 16000

  • CHU Beni Messous

    Algiers, 16000

  • CHU Mustapha

    Algiers, 16000

  • Polyclinique d'el Achour

    Algiers, 16000

  • Polyclinique de Baba Hassen

    Algiers, 16000

  • Cabinet privé, 29 avenue amara Youcef

    Blida, 09000

  • EPH Blida

    Blida, 09000

  • EPH EL Afroun

    Blida, 09000

  • EPH Bologhine

    Bologhine, 16000

  • Cabinet privé, cité des 408 lgmts Bt3

    Boumerdas, 35000

  • CHU BEN BADIS Constantine

    Constantine, 25000

  • Polyclinique de Dély Brahim

    Deli Ibrahim, 16000

  • Polyclinique DRARIA

    Draria, 16000

  • CHU Oran

    Oran, 31000

Other trials in Algeria

Egypt7 sites

  • Clinical Research Center

    Alexandria

  • Ain Shams University Hospitals

    Cairo

  • Air Force Specialized Hospital

    Cairo

  • Al Hussein University Hospital

    Cairo

  • Badr University Hospital

    Cairo

  • Cairo University

    Cairo

  • Tanta University

    Tanta

Other trials in Egypt

Lebanon1 site

  • Hammoud Hospital University Medical Center

    Sidon

Other trials in Lebanon

About this study

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

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
Being tested
Smecta, Smecta placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmectaDrug

    Also called Diosmectite Beaufour

  • Smecta placeboDrug

Study groups in NCT02704091
Study groupRoleWhat they receive
SmectaActive comparator2 sachets, three times a day (TID), during 5 to 9 days
Receives: Drug: Smecta
Smecta placeboPlacebo comparator2 sachets of placebo, TID, during 5 to 9 days
Receives: Drug: Smecta placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From randomisation (Day 1) up to Day 9

Secondary outcomes (7)

  1. 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).

    Measured: From randomisation (Day 1) up to Day 9

  2. 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).

    Measured: From randomisation (Day 1) up to Day 9

  3. 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).

    Measured: From randomisation (Day 1) up to Day 9

  4. Number of Stools, Per 12-Hour Period

    Number of stools, per 12-hour period, was recorded in the DEB.

    Measured: From randomisation (Day 1) up to Day 9

  5. Number of Watery Stools, Per 12-Hour Period

    Number of watery stools, per 12-hour period, was recorded in the DEB.

    Measured: From randomisation (Day 1) up to Day 9

  6. 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.

    Measured: From randomisation (Day 1) up to Day 9

  7. 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.

    Measured: From randomisation (Day 1) up to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2016 (estimated)
  2. Study start17 Mar 2016
  3. Primary completion8 Apr 2019
  4. Study completion8 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704091
Sponsor's protocol ID
F-FR-00250-105
Other IDs
2015-001138-10, 2015
Acronym
ADIASE
Status last verified
Nov 2020
First submitted
4 Mar 2016
Last updated
5 Nov 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Smecta in people with Acute Diarrhoea, run by Ipsen at 71 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Tunisia, Czechia, Poland, Algeria, Egypt and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recovery (time frame: From randomisation (Day 1) up to Day 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in