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    Summary
    EudraCT Number:2009-016529-32
    Sponsor's Protocol Code Number:GWCA0999
    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
    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 ConcernedItaly - Italian Medicines Agency
    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.
    Studio di estensione in aperto, multicentrico, non comparativo, volto a valutare la sicurezza a lungo termine di Sativex spray orale (Sativex; Nabiximols) come terapia aggiuntiva in pazienti affetti da dolore non controllato cronico persistente correlato a tumore.
    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
    Studio in aperto con Sativex nel trattamento del dolore correlato al tumore
    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 number00441980557000
    B.5.5Fax number00441980557111
    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 Sativex Oromucosal Spray
    D.2.1.1.2Name 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-tetraidrocannabinol
    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 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.3.9.3Other descriptive namecannabidiol
    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 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 typePrincipi attivi estratti dalla 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.
    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 safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer.
    Valutare la sicurezza della terapia a lungo termine con Sativex utilizzato come misura aggiuntiva (non episodica) in pazienti con cancro avanzato
    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.
    Valutare il mantenimento dell’effetto durante l’uso a lungo termine di Sativex come terapia aggiuntiva per il sollievo dal dolore non controllato cronico persistente correlato a tumore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion: Patients meeting the following criteria will be considered eligible for this study: - 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.
    Inclusione: i pazienti che soddisfino i seguenti criteri saranno considerati idonei a partecipare allo studio: - completamento dello studio correlato negli ultimi sette giorni; - volontà e capacità di dare il proprio consenso informato scritto; - volontà e capacità di soddisfare tutti i requisiti dello studio
    E.4Principal exclusion criteria
    Exclusion: The patient may not enter the study if ANY of the following apply: - The patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, 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). - 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. - Female patient of child-bearing potential or male patient 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. - 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. - Has significantly impaired hepatic function at the ‘End of Treatment’ Visit of the parent study (ALT >5X upper limit of normal (ULN) or bilirubin (TBL) > 2X ULN). If the ALT or AST >3xULN and (TBL >2xULN or INR >1.5) this patient should not enter the study. This criterion can only be confirmed once the parent study ‘End of Treatment’ Visit laboratory results are available; patients that entered the study and are later found not to meet this criterion should be withdrawn from the study.
    Esclusione: il paziente non è ammesso allo studio se si trova in UNA delle condizioni seguenti: - il paziente assume attualmente cannabis o farmaci a base di cannabinoidi, diversi dall’IMP dello studio correlato e non è disposto a interromperne l’uso 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); - 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; - soggetti di sesso femminile potenzialmente fertili o 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 della 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; - 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; - significativa insufficienza epatica alla Visita di “fine trattamento” dello studio correlato (ALT &gt;5 volte il limite superiore della norma (Upper Limit of Normal, ULN) o bilirubina (TBL) &gt; 2 volte ULN). Se l’ALT o l’AST &gt;3 volte ULN e la TBL &gt;2 volte ULN (o INR &gt;1,5), il paziente non deve essere ammesso allo studio. Il suddetto criterio può essere confermato solo quando siano disponibili gli esiti degli esami di laboratorio effettuati alla Visita di “fine trattamento” dello studio correlato; i pazienti che sono entrati nello studio e che successivamente hanno dimostrato di non essere più conformi al criterio dovranno essere ritirati dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of adverse events (AEs).
    L’endpoint primario è l’incidenza di eventi avversi (EA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment Visit
    Fine della visita di trattamento
    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).
    Gli endpoint secondari sono i seguenti: - scala di valutazione C-SSRS (Columbia Suicide Severity Rating Scale); - parametri vitali; - valutazione di ematologia e biochimica; - media settimanale NRS del dolore; - media settimanale NRS dei disturbi del sonno; - NRS per stipsi; - questionario sulla soddisfazione del paziente (Patient Satisfaction Questionnaire, 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 di fine trattamento per le valutazioni della visita. I dati del diario saranno somministrati durante il tempo delle visite
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 EEA138
    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
    India
    Korea, Republic of
    Mexico
    Taiwan
    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 years0
    E.8.9.1In the Member State concerned months47
    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 months55
    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: 488
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 488
    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 450
    F.4.2.2In the whole clinical trial 976
    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.
    Nei paesi in cui è consentito dalle leggi e regolamenti locali, Sativex sarà messo a disposizione ''gratuitamente'' per pazienti che hanno completato lo studio GWCA0999 quando consigliato dal medico
    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 Decision2013-05-15
    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 trial2016-06-12
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