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    Summary
    EudraCT Number:2009-016529-32
    Sponsor's Protocol Code Number:GWCA0999
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-27
    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 number2009-016529-32
    A.3Full title of the trial
    A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex
    oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in patients with uncontrolled persistent
    chronic cancer related pain.
    Estudio de extensión abierto, multicéntrico y no comparativo para evaluar la seguridad a largo plazo del aerosol bucofaríngeo Sativex (Sativex®; Nabiximols) como tratamiento complementario en pacientes con dolores crónicos persistentes no controlados relacionados con el cáncer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Study of Sativex for the Treatment of Cancer Related Pain
    Estudio abierto de Sativex para el tratamiento de dolor relacionado con Cancer
    A.4.1Sponsor's protocol code numberGWCA0999
    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 SponsorGW Pharma Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportGW Pharma Ltd.
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportOtsuka Pharmaceutical Development & Commercialization Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd.
    B.5.2Functional name of contact pointGW Pharma Ltd. Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury, Wiltshire
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    B.5.6E-mailinfo@gwpharm.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 Oromucosal Spray Sativex Aerosol bucofaríngeo Sativex
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma Ltd.
    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 Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive namedelta-9-tetrahydrocannabinol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive namecannabidiol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeActive ingredients extracted from Cannabis Sativa L. Extractos de ingredientes activos de Cannabis Sativa L.
    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
    Pain in patients with advanced cancer who experience inadequate
    analgesia during optimized chronic opioid therapy.
    Dolor en pacientes con cáncer avanzado que presentan una analgesia inadecuada, incluso con un tratamiento crónico optimizado con opiáceos.
    E.1.1.1Medical condition in easily understood language
    Cancer Pain
    Dolor en cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10058019
    E.1.2Term Cancer pain
    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 safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer.
    Evaluar la eficacia a largo plazo de Sativex cuando se utiliza como medida complementaria (no para dolor intercurrente) en pacientes con cáncer avanzado.
    E.2.2Secondary objectives of the trial
    To assess the maintenance of effect through long-term usage of Sativex as adjunctive therapy for the relief of uncontrolled persistent chronic cancer related pain.
    Evaluar la duración del efecto del uso a largo plazo de Sativex como medida complementaria para aliviar los dolores crónicos persistentes no controlados relacionados con el cáncer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients must fulfill ALL of the following
    criteria:
    - Patient has completed the parent study within the last seven days.
    - Willing and able to give written informed consent.
    - Willing and able to comply with all study requirements.
    Inclusión: Los pacientes que cumplan con los siguientes criterios serán considerados aptos para este estudio:
    - Haber completado el estudio original en los últimos siete días.
    - Voluntad y capacidad de dar el consentimiento informado por escrito.
    - Voluntad y capacidad de cumplir con todos los requisitos del estudio.
    E.4Principal exclusion criteria
    Exclusión: El paciente no puede participar en el estudio si se da ALGUNA de las siguientes situaciones:
    ? El paciente consume actualmente o ha consumido cannabis o medicamentos a base de cannabinoides, a excepción del IMP del estudio original, y no está dispuesto a abstenerse durante el estudio.
    ? Cualquier antecedente propio o familiar inmediato de esquizofrenia, otras enfermedades psicóticas, trastorno grave de la personalidad u otro trastorno psiquiátrico importante que no sea depresión asociada con la afección subyacente.
    ? Cualquier antecedente, conocido o hipotético, de trastorno por dependencia o abuso de sustancias controladas (incluida la dependencia o abuso de opiáceos antes de serle diagnosticado el cáncer), consumo actual excesivo de alcohol (más de 60 g de alcohol puro por día para los hombres y más de 40 g de alcohol puro por día para las mujeres),
    consumo actual de una droga ilegal o consumo actual no recetado de cualquier fármaco de venta con receta.
    ? Tiene epilepsia mal controlada o convulsiones recurrentes (es decir, una o más convulsiones durante el último año).
    ? Ha sufrido un infarto de miocardio o una disfunción cardíaca clínicamente significativa en los últimos 12 meses, o presenta un trastorno cardíaco que, según la opinión del investigador, pondría al paciente en riesgo de sufrir una arritmia clínicamente significativa o un infarto de miocardio.
    ? Las pacientes con capacidad de concebir y los pacientes varones cuya pareja tiene capacidad de concebir, a menos que estén dispuestos a garantizar que ellas o sus parejas usarán un método anticonceptivo efectivo (por ejemplo, anticonceptivos orales, un método de doble barrera, un dispositivo intrauterino), durante el estudio y durante 3 meses después del estudio (sin embargo, un preservativo masculino no se debe utilizar combinado con un preservativo femenino, porque esto puede resultar ineficaz).
    ? La paciente que está embarazada, en periodo de lactancia o planifica un embarazo durante el transcurso del estudio y 3 meses después del estudio.
    ? Cualquier otra enfermedad o trastorno significativo que, según el criterio del investigador, pueda poner en riesgo al paciente debido a la participación en el estudio, o influir en el resultado del estudio o la capacidad del paciente de participar en el mismo.
    ? Tiene la función hepática significativamente deteriorada en la visita de "Finalización del tratamiento" del estudio original (ALT >5 veces el valor del límite superior de normalidad (Upper Limit of Normal, ULN) o bilirrubina total (Total Bilirubin Level, TBL) >2 veces el ULN). Si la ALT o el AST representa >3 veces el ULN (y el TBL >2 veces el ULN o el índice internacional normalizado [International Normalized Ratio, INR] >1,5), este paciente no debe entrar en el estudio. Estos criterios solamente se
    pueden confirmar una vez que estén disponibles los resultados de laboratorio de la visita de "Finalización del tratamiento" del estudio original; los pacientes que se inscribieron en el estudio y se descubrió posteriormente que no cumplían estos criterios se deben retirar del estudio.
    Si los resultados de laboratorio de la visita de "Finalización del tratamiento" del estudio original generan preocupaciones relacionadas con la seguridad, el investigador deberá considerar si es adecuado que el paciente siga participando o no en el estudio de extensión, o si el paciente debe retirarse del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of adverse events (AEs).
    El criterio de valoración principal es la incidencia de acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment Visit
    Visita de finalización de tratamiento
    E.5.2Secondary end point(s)
    The following are the study secondary endpoints:
    - Columbia Suicide Severity Rating Scale (C-SSRS).
    - Vital Signs.
    - Hematology and Biochemistry Assessments.
    - Weekly average NRS Pain.
    - Weekly average Sleep Disruption NRS.
    - Constipation NRS.
    - Patient Satisfaction Questionnaire (PSQ).
    Los criterios de valoración secundarios de este estudio son los siguientes:
    - Escala de Columbia para evaluar la gravedad de las conductas suicidas (C-SSRS).
    - Constantes vitales.
    - Evaluaciones de hematología y bioquímica.
    - Dolor medio semanal en la escala NRS.
    - Alteración de sueño media semanal en la escala NRS.
    - Estreñimiento en la escala NRS.
    - Cuestionario de satisfacción del paciente (PSQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    'End of Treatment Visit' for Visit Assessments. Diary data will be submitted across time/visits
    "Visita de finalizacion de tratamiento para visita de evaluación. Los datos de Diario se enviarán a lo largo del tiempo/visitas
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Australia
    Belgium
    Bulgaria
    Czech Republic
    Estonia
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Poland
    Romania
    Spain
    Taiwan
    United Kingdom
    United States
    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 months7
    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 months7
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 800
    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)
    In those countries where it is permitted by local laws and regulations, Sativex will be made available "free of charge" to patients completing the GWCA0999 trial, when recommended by the physician.
    En aquellos paises donde está permitido por las leyes locales y regulatorias, Sativex estará disponible "sin coste alguno"para aquellos pacientes que completen el Estudio GWCA0999, cuando lo recomiende el Investigador.
    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 Decision2011-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-27
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