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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2015-005151-27
    Sponsor's Protocol Code Number:PREMITO2015
    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:2016-03-18
    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 number2015-005151-27
    A.3Full title of the trial
    Randomized prospective clinical trial to evaluate the rate of early recurrence in bladder cancer in non-muscle invasive between the chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program and post resection treatment with mitomycin C in normothermia.
    Ensayo clínico prospectivo aleatorizado para evaluar la tasa de recurrencia precoz en el Cáncer de vejiga no músculo invasivo entre el uso de quimio-hipertermia (QH) con Mitomicina-C previo a la resección transuretral de vejiga en un programa de Cirugía mayor ambulatoria y el tratamiento con mitomicina C en normotermia post resección.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate recurrence in bladder cancer using two differents strategies of treatment: chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program or post resection treatment with mitomycin C in normothermia
    Ensayo clínico de quimio-hipertermia (QH) con Mitomicina-C previo a la resección transuretral de vejiga frente a Mitomicina post resección en normotermia. Relación con la tasa de recurrencia precoz en el Cáncer de vejiga no músculo invasivo.
    A.3.2Name or abbreviated title of the trial where available
    PREMITO
    A.4.1Sponsor's protocol code numberPREMITO2015
    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 SponsorHospital Universitario de Canarias
    B.1.3.4CountrySpain
    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 supportFundación Canaria de Investigacion Sanitaria
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de canarias
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPlanta 1. Edif hospitalización. Ofra s/n. La Cuesta
    B.5.3.2Town/ cityLa Laguna
    B.5.3.3Post code38320
    B.5.3.4CountrySpain
    B.5.4Telephone number34922678117
    B.5.5Fax number34922677284
    B.5.6E-mailaaldperh@gobiernodecanarias.org
    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 MITOMYCIN-C 40 mg Polvo para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL, S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MITOMYCIN-C 40 mg Polvo para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL, S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    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
    pacientes diagnosticados de neoplasia vesical no músculo invasivo (aspecto macroscópico por cistoscopia y ecográfico) candidatos a RTU-vesical en CMA
    E.1.1.1Medical condition in easily understood language
    patients with vesical cancer non invasive and selected for resection without hospitalization
    pacientes diagnosticados de neoplasia vesical no músculo invasivo candidatos a resección ambulatoria
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the recurrence rate of the intravesical cancer non invasive at 12, 18 and 24 months post MMC instillation using hiperthermia pre uretral resection or normothermia post uretral resection
    Valorar la tasa de recurrencia precoz a 12, 18 y 24 meses del cáncer de vejiga no músculo invasivo de riesgo bajo e intermedio tras la instilación de MMC empleando sistemas de hipertermia previo a la RTU-Vesical (en comparación con el tratamiento estándar).
    E.2.2Secondary objectives of the trial
    To Evaluate tolerance and safety in patients treated with QH MMC instillations of pre-RTU-V patients.
    To Evaluate tolerance of early instillation after TUR-V MMC (standard of care)
    To Explore possible predictors of response (in terms of recurrence and disease progression) to treatment with MMC QH of previous patients to outpatient RTU-V.
    To Analyze the efficiency of treatment with QH and MMC of patients prior to the RTU-V outpatients.
    To analyze the degree of satisfaction of patients after completion of the procedure on an outpatient basis.
    To Compare the quality of life of patients before and after treatment and its possible impact on sexual life.
    To Explore possible predictors of income after QH RTU-bladder prior to outpatients.
    Evaluar la tolerancia y seguridad de los pacientes a las instilaciones con QH con MMC de los pacientes previo a la RTU-V.
    Evaluar tolerancia de la instilación precoz tras RTU-V con MMC (estándar de tratamiento)
    Estudiar posibles factores predictores de respuesta (en términos de recurrencia y progresión de la enfermedad) al tratamiento con QH con MMC de los pacientes previo a la RTU-V ambulatoria.
    Analizar la eficiencia del tratamiento con QH y MMC de los pacientes previo a la RTU-V en régimen ambulatorio.
    Analizar el grado de satisfacción de los pacientes tras la realización del procedimiento en régimen ambulatorio.
    Comparar la calidad de vida de los pacientes pre y post tratamiento y su posible repercusión en la vida sexual.
    Estudiar posibles factores predictores de ingreso tras QH previo a RTU-vejiga en régimen ambulatorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    More than 18 years
    vesical tumor <3cm
    multiple vesical tumors, in total <8 cm and <3cm each one
    ASA less or equal than III
    low or intermediate risk
    - Edad: Mayores de 18 años
    - Neoplasia vesical única < 3cm
    - Neoplasia vesical múltiple < 8 en total y < de 3 cm
    - ASA menor o igual a III
    - Riesgo bajo o Riesgo intermedio:
    E.4Principal exclusion criteria
    - Known hipersensibility to MMC or excipients.
    - Pregnant or lactancy
    - Recent Transuretral resection (<2 years)
    - Vesical in situ carcinoma suspected (Cis).
    - Vesical tumor > 3 cm
    - to have more than 8 tumors
    - Severe cardiopathy
    - Chronic renal insufficinecy
    - Trombocitopenia ( <100.000 platets) ,coagulation disorders and bleeding tendency for other causes.
    - Hipersensibilidad conocida a la MMC o al excipiente.
    - Embarazadas / Lactancia
    - Antecedentes de RTU-V reciente (< 2 años)
    - Sospecha de carcinoma vesical in situ (Cis).
    - Tumor vesical > 3 cm
    - Tener > de 8 tumores
    - Cardiopatía severa
    Insuficiencia renal crónica
    Trombocitopenia ( <100.000 plaquetas) , alteraciones de coagulación y mayor tendencia al sangrado debido a otras causas,
    E.5 End points
    E.5.1Primary end point(s)
    tumoral recurrence post uretral resection
    recurrencia tumoral después de la resección uretral (RTU)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12, 18 and 24 months.
    al año, año y medio y a los dos años.
    E.5.2Secondary end point(s)
    adverse events, predictor factors in the treatment response and hospitalization, life quality and sexual health
    eventos adversos, factores predictores de ingreso o de respuesta al tratamiento, calidad de vida y salud sexual.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 12, 18 and 24 months
    a los 12, 18 y 24 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 No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    existe ciego para el evaluador de la recurrencia por pruebas de imagen
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    mitomicina instalada en normotermia y post resección trans uretral (RTU)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 of the last subject undergoing the trial
    última visita del último paciente reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 83
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state183
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    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)
    Following clinical practice
    Post finalizar el ensayo, se seguirá al paciente según la práctica habitual.
    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 Decision2016-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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