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    Summary
    EudraCT Number:2015-001138-10
    Sponsor's Protocol Code Number:F-FR-00250-105
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2015-001138-10
    A.3Full title of the trial
    Efficacy of diosmectite (Smecta®) in the symptomatic treatment of acute diarrhoea in adults. A multicentre, randomised, double-blind, placebo-controlled, parallel groups study
    Účinnost diosmektitu (Smecta®) při symptomatické léčbě akutního průjmu u dospělých. Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie s paralelními skupinami.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess efficacy of diosmectite (Smecta®) in the symptomatic treatment of acute diarrhoear in adults.
    Studie k posouzení účinnosti diosmektitu (Smecta®) při symptomatické léčbě akutního průjmu u dospělých.
    A.3.2Name or abbreviated title of the trial where available
    ADIASE
    A.4.1Sponsor's protocol code numberF-FR-00250-105
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Pharma SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKCR S.A.
    B.5.2Functional name of contact pointADIASE - helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressPostępu 6
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code02-676
    B.5.3.4CountryPoland
    B.5.6E-mailadiase-helpdesk@kcrcro.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Diosmectite Beaufour
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDiosmectite
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiosmectite
    D.3.9.1CAS number 110070-78-5
    D.3.9.3Other descriptive nameDioctahedral smectite
    D.3.9.4EV Substance CodeSUB20341
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute diarrhoea in adult
    E.1.1.1Medical condition in easily understood language
    Acute diarrhoea in adult
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10055955
    E.1.2Term Acute diarrhoea
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding the time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • To demonstrate that diosmectite efficacy is superior to placebo regarding other efficacy criteria.
    • To assess the clinical tolerance of diosmectite versus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Provision of written informed consent prior to any study related procedures,
    (2) 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.
    (3) 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 without associated alarm symptoms*
    - having started within 48 hours before Visit 1 (first study drug intake time).
    (4) 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, (5) 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.
    *Symptoms considered as alarm symptoms are identified in the exclusion criteria (1)
    **Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional Bowel Disorders. Gastroenterology 2006; 131:1480–91.
    E.4Principal exclusion criteria
    Exclusion criteria related to the acute diarrhoea episode:
    (1) At least one of the following alarm symptoms*
    • bloody diarrhoea*,
    • pus in the stools*,
    • fever 38.0°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
    (2) other episode of acute watery diarrhoea within the previous 30 days,
    (3) persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more than 14 days,
    (4) 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,
    (5) 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:
    (6) 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),
    • colchicine intake, etc.
    (7) anti-diarrhoeal agent intake during the last month,
    (8) any subject requiring repeated intake of a drug with a narrow therapeutic margin (for example, digoxin, theophylline, etc.),
    (9) history of hypersensitivity to diosmectite or its excipients or placebo components,
    (10) 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),
    (11) use of any investigational medication within the last 30 days before entering this study,
    (12) subject who previously entered in a clinical study within the past 30 days.

    Other digestive exclusion criteria:
    (13) History of gastric or intestinal resection, vagotomy,
    (14) known digestive malabsorption disease, including coeliac disease
    (15) known lactose intolerance,
    (16) any suspicion of abdominal surgery need,
    (17) known inflammatory bowel disease.

    Other exclusion criteria:
    (18) Known Human immunodeficiency virus (HIV) positive status,
    (19) known or suspected immunosuppression,
    (20) known severe renal or hepatic insufficiency,
    (21) uncontrolled diabetes of all types and non insulin dependant diabetes during first 6 months of medical treatment and other known endocrine disease,
    (22) history of, or known current, problems with alcohol abuse and/or known drug addiction (cocaine, heroin, hashish…),
    (23) previous enrolment in this study,
    (24) 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,
    (25) Pregnant or lactating women.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to recovery, defined as time from the 1st study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a nonwatery stool, recorded in the Diary Evaluation Booklet (DEB). Consistency will be rated according to the Bristol scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    The secondary endpoints are the following:
    (a) abdominal pain intensity (rated with a 5-point ordinal scale: 0 = absent, 1=mild, 2 =moderate, 3 = severe, 4= very severe) per 12-hour period, recorded in the DEB
    (b) time (hours, minutes) from diarrhoea onset to recovery defined as first formed stool followed by a nonwatery stool, recorded in the DEB
    (c) time (hours, minutes) from first watery stool to the first formed stool, recorded in the DEB
    (d) time (hours, minutes) from the 1st study treatment intake recorded in the eCRF to the last watery stool recorded in the DEB,
    (e) number of stools, per 12-hour period, recorded in the DEB
    (f) number of watery stools, per 12-hour period, recorded in the DEB
    (g) percentage of subjects with associated symptoms such as nausea, vomiting, abdominal pain and anal irritation, per 12-hour period, recorded in the DEB*.
    *Nausea, vomiting, abdominal pain and anal irritation, per 12-hour period will be recorded in the DEB. The percentage of subjects will not be recorded in the DEB.

    The safety and tolerability of diosmectite will be assessed throughout the study by evaluating adverse events (AEs) recorded from subject from the time that the subject gives informed consent until 7 days after the end of the study treatment, vital signs measurements, and physical examination results, and concomitant medication usage.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Safety: Throughout the study until 7 days after the end of the study treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Algeria
    Czech Republic
    Egypt
    Lebanon
    Poland
    Tunisia
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit Last Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 754
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-01-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 854
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-08
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