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    EudraCT Number:2010-022905-17
    Sponsor's Protocol Code Number:GWCA1103
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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.
    Studio in due parti, controllato con placebo, sulla sicurezza ed efficacia di Sativex spray orale (Sativex; Nabiximols) come terapia aggiuntiva per alleviare il dolore persistente cronico non controllato in pazienti con cancro avanzato, che manifestano analgesia inadeguata anche con terapia oppioide cronica ottimizzata.
    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
    Studio con Sativex per il trattamento del dolore neoplastico
    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 number00441980557000
    B.5.5Fax number00441980557111
    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 AuthorisationUnited Kingdom
    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 INNNA
    D.3.9.1CAS number 1972-08-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namedelta-9-tetrahydrocannabinol
    D.3.9.4EV Substance CodeNA
    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 INNNA
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namecannabidiol
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 typePrincipi attivi estratti dalla
    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.
    Dolore in pazienti con cancro avanzato, che manifestano analgesia inadeguata anche con terapia oppioide cronica ottimizzata.
    E.1.1.1Medical condition in easily understood language
    cancer pain
    dolore da cancro
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.
    Valutare l’efficacia di Sativex, in confronto a placebo, quando impiegato come terapia aggiuntiva, per alleviare il dolore persistente cronico non controllato (non dolore episodico intenso) in pazienti con cancro avanzato, che manifestano analgesia inadeguata anche con terapia oppioide cronica ottimizzata.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Sativex compared with placebo on: •Secondary measures of pain. •Sleep disruption. •Constipation. •Opioid consumption. •Change in general function. •Treatment failure. To assess the safety and tolerability of Sativex: •Adverse events (AEs). •Survival. •Suicidal Tendencies (Columbia Suicide Severity Rating Scale - C-SSRS). •Clinical laboratory tests. •Vital signs.
    Valutare l’efficacia di Sativex in confronto a placebo rispetto ai seguenti parametri: •misure di dolore secondarie; •disturbi del sonno; •stipsi; •consumo di oppioidi; •cambiamenti delle funzioni generali; •fallimento del trattamento. Valutare la sicurezza e la tollerabilità di Sativex: •eventi avversi (EA); •sopravvivenza; •tendenze suicide (Columbia Suicide Severity Rating Scale - C-SSRS [Scala di valutazione per le tendenze suicide C-SSRS]); •test clinici di laboratorio; •parametri vitali.
    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 least18 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.
    I pazienti che soddisfino i seguenti criteri saranno considerati idonei a partecipare al periodo di idoneità per il presente studio alla Visita 1: volontà e capacità di dare il proprio consenso informato scritto; età pari o superiore a 18 anni; cancro avanzato diagnosi clinica di dolore correlato al cancro, non del tutto alleviato dal trattamento oppioide ottimizzato attualmente in uso; assunzione di una terapia oppioide di Grado III con dose di mantenimento ottimizzata, preferibilmente con un preparato a rilascio prolungato, con ammessa dose di mantenimento regolare di preparati a rilascio immediato a uso giornaliero continuo; il paziente riceve una terapia oppioide di Grado III con dose di mantenimento giornaliera inferiore o pari a una dose oppioide giornaliera totale di 500 mg/die di equivalenza di morfina (inclusi oppioidi di mantenimento e per il trattamento di dolore episodico intenso); il paziente non assume più di un tipo di analgesia oppioide per il trattamento di dolore episodico intenso; il paziente è disposto a proseguire ad assumere la terapia oppioide di mantenimento in uso alla stessa dose giornaliera, per tutta la durata dello studio, ove possibile; volontà e capacità di soddisfare tutti i requisiti dello studio
    E.4Principal exclusion criteria
    The patient may not enter the study if ANY of the following apply: The patient has 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.
    Il paziente non è ammesso allo studio se si trova in UNA delle condizioni seguenti: il paziente è stato sottoposto a interventi clinici pianificati che condizionerebbero il dolore (ad es., chemioterapia o radioterapia che, in base al giudizio clinico dello sperimentatore, interferirebbero con il livello dolore); il paziente assume o ha assunto cannabis o farmaci a base di cannabinoidi nei 30 giorni antecedenti all’ingresso nello studio e non è disposto a interromperne il consumo per la durata dello studio; qualsiasi anamnesi o anamnesi di un membro stretto della famiglia di schizofrenia, di altri disturbi psicotici, di disturbo di personalità grave o di altro disturbo psichiatrico significativo diverso da depressione associata alla condizione sottostante. qualsiasi anamnesi nota o sospetta di abuso di sostanze/disturbo da dipendenza (incluso/a abuso/dipendenza da oppiati prima della diagnosi del cancro), attuale consumo pesante di alcol (oltre 60 g di alcol puro al giorno per i soggetti di sesso maschile e più di 40 g di alcol puro al giorno per i soggetti femminili), uso attuale di un farmaco illecito o uso attuale non prescritto di un qualsiasi farmaco da prescrizione; epilessia scarsamente controllata o crisi ricorrenti (ovvero una o più crisi nell’ultimo anno); qualsiasi ipersensibilità nota o sospetta a cannabinoidi o a uno qualsiasi degli eccipienti dell’IMP; infarto miocardico o cardiopatia clinicamente significativa insorti negli ultimi 12 mesi o cardiopatia che, in base al giudizio dello sperimentatore, metterebbe il paziente a rischio di un’aritmia clinicamente significativa o infarto miocardico. insufficienza renale significativa come dimostrato da un valore della clearance della creatinina inferiore a 40 ml/min alla Visita 1; significativa insufficienza epatica alla Visita 1 (ALT &gt;5X il limite superiore della norma (Upper Limit of Normal, ULN) o bilirubina (TBL) &gt; 2X ULN). Se l’ALT o l’AST &gt;3X ULN e la TBL &gt;2X ULN (o INR &gt;1,5), il paziente non può essere ammesso allo studio; soggetti di sesso femminile potenzialmente fertili e soggetti di sesso maschile la cui partner sia potenzialmente fertile, salvo nei casi in cui i soggetti siano disposti a garantire l’uso da parte propria o del partner di un metodo di contraccezione efficace, per esempio, contraccezione orale, doppia barriera, dispositivo intrauterino, nel corso dello studio e per i tre mesi successivi (si esclude tuttavia l’uso del profilattico maschile in concomitanza con l’uso di un profilattico femminile perché l’uso congiunto di questi due metodi potrebbe non essere efficace); donne in stato di gravidanza, in allattamento o che pianifichino una gravidanza nel corso dello studio o nei tre mesi successivi; pazienti che abbiano ricevuto un IMP non approvato nei 30 giorni antecedenti alla Visita 1; qualsiasi altro disturbo significativo o che, a parere dello sperimentatore, potrebbe mettere il paziente a rischio a causa della partecipazione allo studio oppure condizionare il risultato dello studio oppure la capacità del paziente di partecipare allo studio; viaggiare al di fuori del Paese di residenza pianificato durante lo studio; pazienti precedentemente arruolati nella Parte A di questo studio o in qualsiasi altra sperimentazione clinica di Sativex per il trattamento del dolore correlato a cancro
    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.
    L’endpoint primario è la variazione media dal basale alla fine del trattamento del punteggio di dolore medio nella scala NRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    the last 4 days of IMP treatment in part B
    gli ultimi 4 giorni di trattamento nella parte B
    E.5.2Secondary end point(s)
    Key secondary endpoints with Type I error controlled by a hierarchical testing procedure:

    • Percentage 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

    Other secondary endpoints:

    • Subject (patient) Global Impression of Change (SGIC)
    • Patient Satisfaction Questionnaire (PSQ)
    • Change from baseline in mean total, maintenance and break-through opioid dose (morphine equivalence)
    • 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.
    Gli endpoint secondari chiave sono l’errore di tipo I controllato con una procedura di verifica gerarchica:

    • miglioramento in percentuale dal periodo di idoneità alla fine del trattamento del punteggio di dolore medio nella scala NRS;
    • variazione rispetto al basale del dolore peggiore nella NRS media;
    • variazione rispetto al basale nell’NRS media per i disturbi del sonno.

    Altri endpoint secondari:

    • impressione di cambiamento globale soggettiva (del paziente) (Subject Global Impressione of Change, SGIC);
    • questionario sulla soddisfazione del paziente (Patient Satisfaction Questionnaire, PSQ);
    • variazione rispetto al basale nella dose di oppioidi media totale, di mantenimento e per il trattamento di dolore episodico intenso (equivalenza di morfina);
    • variazione rispetto al basale nell’NRS per la stipsi;
    • impressione globale di cambiamenti delle funzioni generali da parte del medico (Physician Global Impression of Change in general function, PGIC);
    • tempo al ritiro per qualsiasi motivo durante la Parte B;
    • ritiro dalla Parte B per mancanza di efficacia.
    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 end point - i.e last 4 days of IMP treatment in part B. The other end of treatment values will use the visit 5 assessment data.
    I dati di diario basati sui valori di fine trattamento saranno calcolati con le stesse regole per l'end point primario - cioè ultimi 4 giorni di trattamento IMP nella parte B. Gli altri valori di fine trattamento useranno i dati di valutazione 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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months41
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months41
    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.1.1.2Preterm 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: 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 state10
    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)
    see protocol
    vedere protocollo
    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 Decision2012-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-10
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