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    The EU Clinical Trials Register currently displays   33594   clinical trials with a EudraCT protocol, of which   5439   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-002784-24
    Sponsor's Protocol Code Number:2011-11
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-12
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-002784-24
    A.3Full title of the trial
    STRONG TREAT 1 to 4 - randomized, open-label, multi centre, phase III clinical trial on multiple versus single dose of ivermectin for the treatment of strongyloidiasis
    STRONG TREAT 1 to 4 - Ensayo clínico multicéntrico randomizado abierto fase III para comparar dosis única versus dosis múltiple de ivermectina en el tratamiento de la estrongiloidiasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing different doses of the drug ivermectin for the treatment of strongyloidiasis
    Estudio que compara diferentes dosis del fármaco ivermectina para el tratamiento de la estrongiloidiasis
    A.3.2Name or abbreviated title of the trial where available
    STRONG TREAT 1 to 4
    STRONG TREAT 1 to 4
    A.4.1Sponsor's protocol code number2011-11
    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 SponsorSacro Cuore - Don Calabria Hospital
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCohemi project
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSacro Cuore - Don Calabria Hospital
    B.5.2Functional name of contact pointCentre for Tropical Diseases
    B.5.3 Address:
    B.5.3.1Street AddressVia Sempreboni 5
    B.5.3.2Town/ cityNegrar (Verona)
    B.5.3.3Post code37024
    B.5.3.4CountryItaly
    B.5.4Telephone number+390456013563
    B.5.6E-maildora.buonfrate@sacrocuore.it
    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 stromectol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    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 INNivermectin
    D.3.9.1CAS number 70288-86-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameIVERMECTIN
    D.3.9.4EV Substance CodeSUB12089MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    strongyloidiasis
    estrongiloidiasis
    E.1.1.1Medical condition in easily understood language
    parasitic infection
    Infección parasitaria
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare different dose schedules of ivermectin for the treatment of strongyloidiasis
    Comparar diferentes dosis de ivermectina para el tratamiento de la estrongiloidiasis
    E.2.2Secondary objectives of the trial
    Safety and tolerability of ivermectin
    Seguridad y tolerabilidad de la ivermectina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients older than 5 years weighting > 15 kg. Current residence in non endemic areas. Diagnosis of strongyloidiasis by positive stool examination and/or stool culture AND positive serology at any titer OR positive serology at "high" titer. Informed consent.
    Pacientes de ambos sexos mayores de 5 años y con peso superior a 15Kg. Residencia actual en áreas no endémicas. Diagnóstico de estrongiloidiasis mediante examen parasitológico en heces y/o cultivo Y serología positiva a cualquier título O serología positiva a título "alto". Consentimiento informado
    E.4Principal exclusion criteria
    Pregnant or lactating women. CNS diseases. Disseminated strongyloidiasis. Immunosuppressed patients. Lack of informed consent. Previous treatment (last year) with ivermectin
    Embarazo o lactancia. Enfermedad del Sistema Nervioso Central. Estrongiloidiasis diseminada. Pacientes inmunosuprimidos. Falta de consentimiento informado. Tratamiento previo (durante el último año) con ivermectina.
    E.5 End points
    E.5.1Primary end point(s)
    Clearance of strongyloidiasis at T2 (time 2: 12 months after recruitment)
    Desaparición de la infección en T2 (Tiempo 2: 12 meses tras el reclutamiento)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    All-cause mortality during the 12 months of follow up. Patients with partial response to the treatment. Patients with adverse reactions. Patients with symptoms cleared/not cleared at T2. Patients with incread ALT at day 17. Patients with decreased WBC count at day 17. Average difference in ALT and WBC count at day 17, compared to baseline. Average difference in eosinophil count at T2, compared with baseline
    Todas las causas de mortalidad durante los 12 meses de seguimiento. Pacientes con respuesta parcial al tratamiento. Pacientes con reacciones adversas. Desaparición de los síntomas en T2 (Tiempo 2). Pacientes con ALT elevada en el día 17. Pacientes con recuento de leucocitos disminuido en el día 17. Diferencia media en ALT y recuento de leucocitos en el día 17 respecto a los basales. Diferencia media de recuento de eosinófilos en T2 (Tiempo 2) comparado con el basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    diferentes dosis de ivermectina
    different dose schedule of ivermectin
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Peru
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    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 2013-07-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 400
    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 Decision2013-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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