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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2007-000155-34
    Sponsor's Protocol Code Number:2 79 52030 207
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-000155-34
    A.3Full title of the trial
    PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA.
    Estudio en fase IIIb, multicéntrico, abierto, de un solo brazo, para evaluar la seguridad y eficacia de Lanreotida Autogel 120 mg, administrado cada 28 días, como tratamiento médico principal en pacientes acromegálicos con macroadenoma
    A.4.1Sponsor's protocol code number2 79 52030 207
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBeaufour Ipsen Pharma
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SOMATULINA AUTOGEL
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    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 namelanreotida Autogel 120 mg
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLANREOTIDA
    D.3.9.1CAS number 108736352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    ACROMEGALIA ASOCIADA A MACROADENOMA DE LA GLÁNDULA PITUITARIA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de Lanreotida Autogel 120 mg cuando se utiliza como tratamiento médico primario en pacientes con acromegalia de novo no tratados con macroadenoma, valorados mediante la evaluación de la variación del volumen de los tumores pituitarios en la Semana 48 (tras 12 inyecciones – V5) en comparación con el volumen basal (V1).
    Una reducción del 20% del volumen basal se considerará clínicamente significativa (medida por RM en V1)
    E.2.2Secondary objectives of the trial
    (1) Evaluar la variación del volumen tumoral tras 3 inyecciones (V3) y 6 inyecciones (V4) en comparación con V1,
    (2) Evaluar la variación de los niveles de GH, IGF-1 y prolactina* en todos los hitos temporales en comparación con los basales,
    (3) Evaluar la actividad terapéutica de Lanreotida Autogel 120 mg como tratamiento médico primario sobre:
    - Los síntomas de la acromegalia,
    - La calidad de vida (utilizando AcroQOL)**
    (4) Evaluar la seguridad en base a:
    - Acontecimientos adversos, examen clínico, signos vitales,
    - Tolerancia a la glucosa,
    - Hematología y bioquímica estándar,
    - Ecografía de la vesícula biliar.
    *La prolactina sólo se evaluará en pacientes que presenten un incremento inicial del nivel de prolactina en V1 (20ng/ml < prolactina  100 ng/ml).
    **El AcroQOL sólo se evaluará en los países en los que se disponga de una traducción validada.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) El paciente ha dado su consentimiento informado con anterioridad a cualquier procedimiento relacionado con el estudio,
    (2) El paciente es hombre o mujer y su edad es entre 18 y 75 años, ambas inclusive,
    (3) Diagnóstico de acromegalia definido como i) nadir de GH > 1 ng/ml evaluado mediante un test de tolerancia oral a la glucosa para pacientes no diabéticos (resultados del laboratorio central) o una media del nivel de GH > 1 ng/ml en base a 5 muestras recogidas cada 10-15 minutos en pacientes diabéticos (perfil de GH – resultados del laboratorio central) Y ii) concentraciones IGF-1 elevadas por encima de los valores normales por edad y sexo para pacientes diabéticos y no diabéticos (resultados del laboratorio central),
    (4) El paciente tiene un adenoma pituitario con un diámetro  10 mm en base a la lectura central de la Resonancia Magnética (RM),
    (5) El paciente no tiene defectos en el campo de visión identificados en la evaluación visual, realizada por el Analizador de Campos Visuales de Goldman y el Perímetro Estático Automático del Campo Visual.
    E.4Principal exclusion criteria
    (1) El paciente tiene historial de hipersensibilidad a Lanreotida o fármacos de estructura química similar,
    (2) El paciente ha recibido algún fármaco sin licencia en los 30 días anteriores a la visita de evaluación o está previsto que reciba algún otro fármaco sin licencia distinto a Lanreotida Autogel durante el curso del estudio,
    (3) El paciente puede requerir durante el estudio tratamiento con análogos de la somatostatina distintos a Lanreotida Autogel 120 mg, agonista de la dopamina, antagonista de los receptores de GH (Pegvisomant) y Ciclosporina,
    (4) La paciente es una mujer con riesgo de embarazo durante el curso del estudio y no está utilizando un método anticonceptivo aceptable. Las mujeres en edad fértil deben proporcionar un test de embarazo negativo al inicio del estudio y deben usar un método de contracepción oral, de doble barrera (preservativo con gel, supositorios, crema o espuma espermicida; diafragma con espermicida; o preservativo masculino y diafragma con espermicida), anticonceptivo inyectable o un dispositivo intrauterino. No se considera edad fértil potencial las post-menopausias de al menos 1 año, esterilización quirúrgica o histerectomía de al menos tres meses antes del inicio del estudio,
    (5) La paciente está embarazada o en período de lactancia,
    (6) El paciente tiene historial, previo o actual, de problemas de abuso de alcohol,
    (7) El paciente tiene alguna condición mental que hace que no pueda entender la naturaleza, alcance y posibles consecuencias del estudio, y/o se evidencia una actitud no cooperativa,
    (8) Valores anormales en los resultados de las pruebas basales efectuadas al paciente, alguna otra condición(es) médica(s), o resultados de laboratorio, que, en opinión del Investigador, podrían poner en peligro la seguridad del paciente o disminuir la posibilidad de obtener los datos satisfactorios necesarios para conseguir el(los) objetivo(s) del estudio,
    (9) El paciente ha sido sometido a cirugía pituitaria o radioterapia pituitaria antes de la incorporación al estudio,
    (10) El paciente ha sido tratado previamente con análogos de la somatostatina,
    (11) El paciente ha recibido un agonista de la dopamina o un antagonista de los receptores de GH (Pegvisomant) antes de la incorporación al estudio,
    (12) Se espera que el paciente requiera cirugía pituitaria (adenomectomía) o reciba radioterapia durante el curso del estudio,
    (13) Pacientes que se sospeche puedan padecer prolactinoma asociado: nivel de prolactina > 100 ng/ml (laboratorio central),
    (14) Pacientes alérgicos al Gadolinium (contraste utilizado par ala RM) o con insuficiencia renal agcutae o crónica grave (tasa de filtración glomerular <30 ml/min/1.73m2)
    (15) Pacientes con trastornos del nervio óptico, congénitos o adquiridos, conocidos por el Investigador, o cualquier anomalía visual que pueda influir potencialmente en la interpretación del campo visual (por ejemplo glaucoma, anomalías del disco óptico congénitas, drusen, retinitis pigmentaria….)
    (16) Pacientes que pongan en conocimiento del investigador una patología congénita o adquirida del nervio óptico, o cualquier anomalía visual que pueda influenciar en la interpretación del campo visual (p.e. glaucoma, anomalía congénita del disco óptico, drusas, retinitis pigmentaria...)
    En ningún caso podrán incluirse los pacientes más de una vez.
    E.5 End points
    E.5.1Primary end point(s)
    El indicador de eficacia principal será el porcentaje de pacientes con una reducción significativa en el volumen tumoral, comparando las RM realizadas en V1 y V5 (sem 48)
    Se realizará una evaluación ciega y centralizada de todas las RM.
    Una reducción del 20% del volumen de la V1 se considerará clínicamente significativa.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio se define como la última visita realizada al último paciente participante en el estudio.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 100
    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 Decision2008-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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