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    Summary
    EudraCT Number:2012-002291-13
    Sponsor's Protocol Code Number:DIALAGG
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002291-13
    A.3Full title of the trial
    Multicentre, prospective, double-blind, two-armed, placebo-controlled phase III study to evaluate the efficacy and safety of the treatment of diarrhoea with Lactobacillus rhamnosus GG (InfectoDiarrstop LGG Mono Beutel) in infants and toddlers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International trial involving numerous sites in several countries to investigate the efficacy in shortening diarrhoea and safety for small children (infants and toddlers) by treatment with Lactobacillus rhamnosus GG (brand name: InfectoDiarrstop LGG Mono Beutel)
    A.3.2Name or abbreviated title of the trial where available
    Diarrhoea therapy with Lactobacillus rhamnosus GG
    A.4.1Sponsor's protocol code numberDIALAGG
    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 SponsorInfectoPharm - Arzneimittel und Consilium GmbH
    B.1.3.4CountryGermany
    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 supportInfectoPharm - Arzneimittel und Consilium GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEcron Acunova GmbH
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressHahnstrasse 70
    B.5.3.2Town/ cityFrankfurt/Main
    B.5.3.3Post code60528
    B.5.3.4CountryGermany
    B.5.4Telephone number+496966 80 30 0
    B.5.5Fax number+496966 80 30 29
    B.5.6E-mailSimon.Berberich@ecronacunova.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 Infectodiarrstop LGG Mono Beutel
    D.2.1.1.2Name of the Marketing Authorisation holderInfectopharm Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNLactobacillus rhamnosus GG
    D.3.9.1CAS number ./.
    D.3.9.2Current sponsor code./.
    D.3.9.3Other descriptive name./.
    D.3.9.4EV Substance Code./.
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5x10E9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 infants and toddlers
    Akute Diarrhoe bei Säuglingen und Kleinkindern
    E.1.1.1Medical condition in easily understood language
    Acute diarrhoea in infants and toddlers
    Akute Durchfallerkrankung bei Säuglingen und Kleinkindern
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000706
    E.1.2Term Acute diarrhea
    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
    Duration of diarrhoea (time until therapeutic success, i.e. end of diarrhoea, defined as ≤ 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment)
    Dauer des Durchfalls (Zeit bis zum Therapieerfolg, d.h. Ende des Durchfalls, definiert als ≤ 3 wässrige und/oder lose Stühle pro Tag innerhalb der letzten 2 Tage ohne Wiederauftreten des Durchfalls bis zum Ende der Behandlung)
    E.2.2Secondary objectives of the trial
    • Therapeutic success at the control visit on Day 5
    • Therapeutic success at the final examination on Day 10
    • Termination due to inefficacy on Day 2 and until Day 10
    • Number of watery and/or loose stools on each day during the treatment phase
    • Number of bloody stools on each day during the treatment phase
    • Number of patients with vomiting analysed for each day during the treatment phase
    • Dropout cases (number and reasons)
    • Adverse events (AEs) (incl. seriousness and relationship to trial drug)
    • Therapieerfolg beim Kontrollbesuch an Tag 5
    • Therapieerfolg bei der Enduntersuchung an Tag 10
    • Abbruch aufgrund Wirkungslosigkeit an Tag 2 und bis zum Tag 10
    • Anzahl der wässrigen und/oder losen Stühle an jedem Tag während der Behandlungsphase
    • Anzahl der blutigen Stühle an jedem Tag während der Behandlungsphase
    • Anzahl der Patienten mit Erbrechen ausgewertet für jeden Tag während der Behandlungsphase
    • Studienabbrecher (Anzahl und Gründe)
    • Unerwünschte Ereignisse (UEs), inkl. Schweregrad und Bezug zur Studienmedikation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Informed consent to trial participation in writing encompassing consent to data recording and verification procedures, is to be given by both parents (or legal representatives, if applicable) of the patient before the first administration of trial medication
    • Male or female infants or toddlers aged 28 days to 24 months
    • Clinical diagnosis of diarrhoea (> 3 watery and/or loose stools during the past 24 hours)
    • Vorliegende Einverständniserklärung beider Eltern (oder Erziehungsberechtigter, falls zutreffend) zur Studienteilnahme inkl. Zustimmung zur Datenaufzeichnung und Prozeduren zum Datenabgleich vor Einnahme der ersten Studienmedikation
    • Männliche und weibliche Säuglinge oder Kleinkinder im Alter von 28 Tagen bis zu 24 Monaten
    • Klinische Diagnose des Durchfalls (> 3 wässrige und/oder lose Stühle während der letzten 24 Stunden)
    E.4Principal exclusion criteria
    • Diarrhoea for more than 3 days (72 hours)
    • Diarrhoea after stay abroad
    • Bloody stools
    • Fever
    • Dehydration > 5% (loss in weight)
    • Systemic treatment with antibiotics (currently or during the past 24 hours)
    • Malnutrition (according to clinician’s assessment)
    • Severe or chronic disease of the gastrointestinal tract
    • Short bowel syndrome
    • Phenylketonuria
    • Clinically relevant primary or secondary immunodeficiency
    • Malignant tumour, chemotherapy, or radiotherapy (currently or during the past 6 months)
    • Other severe diseases that the investigator assesses as conflicting with the participation
    • Premature infants (gestational age < 38 weeks)
    • Lactose intolerance
    • Hypersensitivity to the active pharmaceutical ingredient or any other ingredient of the trial medication
    • Intake of highly dosed probiotics (> one billion of colony forming units (CFU)/day during the past 7 days before inclusion)
    • Other antidiarrhoeal medical therapies (currently or during the past 7 days)
    • Inability of the parents to understand the instructions of the trial
    • Obvious unreliability of the parents or missing willingness to cooperate
    • Known addiction of the parents to alcohol, medicaments, or drugs
    • Dependency of the child or the parents on the sponsor or on an investigator
    • Participation in a clinical trial during the past 30 days
    • Participation of a sibling in the present clinical trial
    • Previous participation in the present clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the duration of diarrhoea.
    Duration of diarrhoea is defined as the time from randomisation to the end of diarrhoea (defined as ≤ 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment). The first day without diarrhoea will be the day of end of diarrhoea.
    This definition also applies to patients who prematurely terminate the treatment with ≤ 3 watery and/or loose stools per day during the past 2 days (i.e. due to an already reached “end of diarrhoea”).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Presumably March 2014
    E.5.2Secondary end point(s)
    Therapeutic success at the control visit on Day 5 (=yes, if end of diarrhoea defined as ≤ 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no)

    Therapeutic success at the final examination on Day 10 (=yes, if end of diarrhoea defined as ≤ 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no)

    Termination due to inefficacy on Day 2 and until Day 10

    Number of watery and/or loose stools on each day during the treatment phase

    Number of bloody stools on each day during the treatment phase

    Number of patients with vomiting analysed for each day during the treatment phase

    Grade of dehydration (the grade of dehydration will be determined by the investigator at each visit as mild (< 5%), moderate (5-10%), or severe (> 10%))
    E.5.2.1Timepoint(s) of evaluation of this end point
    Presumably March 2014
    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 Yes
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 150
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and toddlers
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 150
    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)
    There is no further treatment planned after the trial participation in the trial has ended.
    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 Decision2012-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-25
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