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    EudraCT Number:2010-022905-17
    Sponsor's Protocol Code Number:GWCA1103
    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:2011-10-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-022905-17
    A.3Full title of the trial
    A two-part, placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy
    Estudio sobre la seguridad y eficacia del aerosol bucofaríngeo Sativex (Sativex®; Nabiximols), controlado con placebo, de dos partes, como tratamiento complementario para aliviar dolores crónicos persistentes no controlados en pacientes con cáncer avanzado y analgesia inadecuada, incluso con un tratamiento crónico optimizado con opioides.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Sativex for the Treatment of Cancer Related Pain.
    Estudio de Sativex para el tratamiento de dolor asociado a cáncer.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberGWCA1103
    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
    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. name Sativex Oromucosal Spray
    D. 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.3.8INN - Proposed INNTetrahydrocannabinol Botanical Drug Substance (THC BDS)
    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.3.8INN - Proposed INNCannabidiol Botanical Drug Substance (CBD BDS)
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeActive ingredients extracted from Cannabis Sativa L.
    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 placeboOromucosal spray
    D.8.4Route of administration of the placeboOromucosal use
    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 have inadequate analgesia even with optimized chronic opioid therapy.
    Dolor en pacientes con cáncer avanzado que presentan una analgesia inadecuada, incluso con un tratamiento crónico optimizado con opioides.
    E.1.1.1Medical condition in easily understood language
    Cancer pain
    Dolor de cáncer
    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 efficacy of Sativex, compared with placebo, when used as an adjunctive measure, in relieving uncontrolled persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy.
    Evaluar la eficacia de Sativex, comparada con placebo, cuando se utiliza como medida complementaria para aliviar dolores crónicos persistentes no controlados (no un dolor intercurrente) en pacientes con cáncer avanzado, que presentan analgesia inadecuada incluso con un tratamiento crónico optimizado con opioides.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Sativex compared with placebo on:
    -Secondary measures of pain
    -Sleep disruption
    -Opioid consumption
    -Change in General function
    -Treatment failure

    To evaluate the safety and tolerability of Sativex compared with placebo through the following assessments:
    -Adverse Events (AE)
    -Suicidal Tendencies (Columbia Suicide Severity Rating Scale - C-SSRS)
    -Clinical laboratory tests
    -Vital signs
    Evaluar la eficacia de Sativex comparada con placebo en:
    -Mediciones secundarias del dolor
    -Alteración del sueño
    -Consumo de opioides
    -Cambio en la función general
    -Fracaso del tratamiento
    Evaluar la seguridad y la tolerabilidad de Sativex comparado con placebo a través de las siguientes evaluaciones:
    -Acontecimientos adversos (AE)
    -Tendencias suicidas (Escala de Columbia para evaluar la gravedad de las conductas suicidas, C-SSRS)
    -Análisis clínicos de laboratorio
    -Constantes vitales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting the following criteria will be considered suitable to enter into the Eligibility Period for this study at Visit 1:
    -Willing and able to give written informed consent.
    -The patient is at least 18 years of age or older.
    -The patient has advanced cancer.
    -The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with his or her current optimized opioid treatment.
    -The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations.
    -The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids).
    -The patient is using no more than one type of break-through opioid analgesia.
    -The patient is willing to continue to take their maintenance opioid therapy at the same daily dose, throughout the duration of the study where possible.
    -Willing and able to comply with all study requirements.
    Los pacientes que cumplan con los siguientes criterios serán considerados aptos para inscribirse en el período de idoneidad para este estudio en la visita 1:
    -Estar dispuestos a y poder otorgar un consentimiento informado por escrito.
    -El paciente tiene 18 años o más.
    -El paciente tiene cáncer avanzado
    -El paciente tiene un diagnóstico clínico de dolor relacionado con cáncer, que no puede ser aliviado por completo con su actual tratamiento optimizado con opioides.
    -El paciente recibe una dosis optimizada de mantenimiento del tratamiento con opioides del Escalón III, preferentemente con una preparación de liberación sostenida, pero también permitiendo una dosis de mantenimiento regular de uso durante las 24 horas de preparaciones de liberación inmediata.
    -El paciente recibe una dosis diaria de mantenimiento del tratamiento con opioides del Escalón III menor o equivalente a la dosis total diaria de opioides de 500 mg/día de la equivalencia de morfina (incluyendo opioides de mantenimiento y de rescate).
    -El paciente utiliza únicamente un solo tipo de analgesia de rescate con opioides.
    -El paciente está dispuesto a continuar el tratamiento de mantenimiento con opioides en la misma dosis diaria, a lo largo del estudio cuando sea posible.
    -Estar dispuesto a y poder cumplir con todos los requisitos del estudio.
    E.4Principal exclusion criteria
    The patient may not enter the study if ANY of the following apply:
    -Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain).
    -The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
    -Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
    -Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug.
    -Has poorly controlled epilepsy or recurrent seizures (i.e., one or more seizure during the last year).
    -Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
    -Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
    -Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40 mL/min at Visit 1.
    -Has significantly impaired hepatic function at Visit 1 (ALT >5X upper limit of normal (ULN) or bilirubin (TBL) > 2X ULN). If the ALT or AST >3X ULN and the TBL >2X ULN (or INR >1.5), this patient should not enter the study.
    -Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
    -Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    -Patients who have received a non-approved IMP within 30 days of Visit 1.
    -Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient?s ability to participate in the study.
    -Travel outside the country of residence planned during the study.
    -Patients previously enrolled into Part A of this study or any other Sativex clinical trial for Cancer Pain.
    El paciente no puede entrar en el estudio ni continuar en el mismo si se presenta ALGUNA de las siguientes situaciones:
    -El paciente tiene una intervención clínica planificada que afectaría su dolor (p. ej. radioterapia o quimioterapia, las cuales, según el juicio clínico del investigador, producirían un efecto en el dolor).
    -El paciente actualmente consume o consumió cannabis o medicamentos a base de cannabinoides dentro de los 30 días desde el ingreso en el estudio 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 importantes que no sea depresión asociada con la afección subyacente.
    -Cualquier antecedente, conocido o hipotético, de trastorno por dependencia o abuso de sustancias (incluyendo dependencia o abuso de opioides antes de ser diagnosticado con 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 un fármaco ilícito o consumo actual no recetado de cualquier fármaco de venta con receta.
    -Tiene epilepsia mal controlada o ataques recurrentes (es decir, una o más convulsiones durante el año).
    -Cualquier hipersensibilidad conocida o hipotética a los cannabinoides o a cualquiera de los excipientes del IMP.
    -Ha experimentado un infarto del miocardio o una disfunción cardíaca clínicamente significativa dentro de los últimos 12 meses, o presenta un trastorno cardíaco que, según la opinión del investigador, pondría al paciente en riesgo de una arritmia clínicamente significativa o un infarto de miocardio.
    -Presenta un deterioro significativo de la función renal como evidencia de la depuración de creatinina inferior a 40 ml/min en la visita 1.
    -Tiene la función hepática significativamente deteriorada en la visita 1 (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.
    -Las pacientes mujeres con posibilidades de concebir y los pacientes varones cuya pareja tiene posibilidades 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 por 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 mujer que está embarazada, en período de lactancia o planifica un embarazo durante el transcurso del estudio y por 3 meses después del estudio.
    -Los pacientes que recibieron un IMP no autorizado en el plazo de los 30 días de la visita 1.
    -Cualquier otra enfermedad o trastorno significativo que, según el criterio del investigador, puede 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.
    -Tener planificado un viaje fuera del país de residencia durante el estudio.
    -Los pacientes que ya se inscribieron en la Parte A de este estudio o en cualquier otro ensayo clínico de Sativex para dolor provocado por cáncer.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean change from baseline to the end of treatment in NRS average pain score.
    El criterio de valoración primario es el cambio medio desde el inicio en la puntuación media de dolor promedio en la NRS hasta el fin del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The last 4 days of IMP treatment in Part B.
    Los últimos 4 días del tratamiento de IMP de la Parte B.
    E.5.2Secondary end point(s)
    The following key secondary endpoints will have their Type I error controlled by a hierarchical testing procedure:
    -Percent improvement from the eligibility period to the end of treatment in NRS average pain score.
    -Change from baseline in mean NRS worst pain.
    -Change from baseline in mean Sleep Disruption NRS.
    The remaining secondary efficacy endpoints are:
    -Subject (patient) Global Impression of Change (SGIC).
    -Patient Satisfaction Questionnaire (PSQ).
    -Change from baseline in mean total opioid (morphine equivalence) use.
    -Change from baseline in mean daily maintenance dose opioid (morphine equivalence) use.
    -Change from baseline in mean break-through opioid usage (morphine equivalence) use.
    -Change from baseline in constipation NRS.
    -Physician Global Impression of Change in general function (PGIC).
    -Time to withdrawal for any reason during Part B.
    -Withdrawal from Part B due to lack of efficacy.
    Los criterios de valoración secundarios tendrán su error de tipo I controlado por un procedimiento jerárquico de pruebas:
    -La mejoría del porcentaje desde el período de idoneidad hasta el fin del tratamiento en la puntuación media de dolor en la NRS.
    -Cambio desde el inicio en la media del peor dolor en la NRS.
    -Cambio desde el inicio en la media de la alteración de sueño en la NRS.
    Los criterios de valoración de eficacia secundarios restantes son los siguientes:
    -Impresión global del sujeto (paciente) sobre el cambio (SGIC).
    -Cuestionario de satisfacción del paciente (PSQ).
    -Cambio desde el inicio en la media del uso total de opioides (equivalencia de morfina).
    -Cambio desde el inicio en la media del uso de la dosis diaria de mantenimiento con opioides (equivalencia de morfina).
    -Cambio desde el inicio en la media del uso de la dosis de rescate con opioides (equivalencia de morfina).
    -Cambio desde el inicio del estreñimiento en la NRS.
    -Impresión global del médico sobre el cambio en la función general (PGIC).
    -Momento de retirarse por cualquier motivo durante la Parte B.
    -Interrupción de la Parte B debida a ineficacia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The diary data based end of treatment values will be calculated using the same rules as for the primary endpoint ? i.e. last 4 days of IMP treatment in Part B. The other end of treatment values will use the Visit 5 assessment data.
    Los valores de inicio y de fin de tratamiento basados en los datos del diario se calcularán utilizando las mismas reglas que para el criterio de valoración primario por ejemplo los últimos 4 días del tratamiento de IMP de la Parte B. Otros valores de fin del tratamiento usarán los datos de evaluación de la visita 5.
    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. 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Korea, Republic of
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 540
    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)
    Please see protocol
    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
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