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    Summary
    EudraCT Number:2015-004227-31
    Sponsor's Protocol Code Number:1312/BP
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-04
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-004227-31
    A.3Full title of the trial
    Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life
    Klinische Pilotstudie zur Überprüfung des Einflusses einer perioperativen Einnahme des synthetischen Cannabinoids Nabilon im Rahmen stabilisierender Wirbelsäulenoperationen auf die Operationsbewältigung und das Schmerzempfinden von Patienten mit stark reduzierter Lebensqualität
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life
    Klinische Pilotstudie zur Überprüfung des Einflusses einer perioperativen Einnahme des synthetischen Cannabinoids Nabilon im Rahmen stabilisierender Wirbelsäulenoperationen auf die Operationsbewältigung und das Schmerzempfinden von Patienten mit stark reduzierter Lebensqualität
    A.3.2Name or abbreviated title of the trial where available
    Cannabinoid-Spinal-Fusion-Study
    Cannabinoid-WS-OP-Studie
    A.4.1Sponsor's protocol code number1312/BP
    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 SponsorOA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOrthopädisches Spital Speising GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportAOP Orphan Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiener Pflege-, Patientinnen- und Patientenanwaltschaft
    B.5.2Functional name of contact pointPatientinnen- und Patientenanwalt
    B.5.3 Address:
    B.5.3.1Street AddressSchönbrunner Str. 108
    B.5.3.2Town/ cityWien / Vienna
    B.5.3.3Post code1050
    B.5.3.4CountryAustria
    B.5.4Telephone number004315871204
    B.5.5Fax number004315863699
    B.5.6E-mailpost@wpa.wien.gv.at
    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 Canemes 1 mg Kapseln
    D.2.1.1.2Name of the Marketing Authorisation holderAOP Orphan Pharmaceuticals AG, Vienna, Austria
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNabilone
    D.3.9.1CAS number 510022 - 71-
    D.3.9.3Other descriptive nameNabilone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) 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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spine disease
    Wirbelsäulenerkrankung
    E.1.1.1Medical condition in easily understood language
    Spine disease
    Wirbelsäulenerkrankung
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Gaining first insights into the effects of pre-, peri- and postoperative
    cannabinoid intake on the physical and psychological coping with surgery
    as well as on the pain perception of patients with severely reduced quality of
    life
    Gewinnung erster Erkenntnisse über die Auswirkungen einer prä-, peri- und postoperativen Cannabinoid-Einnahme auf die physische und psychische Operationsbewältigung sowie das Schmerzempfinden von Patienten mit stark reduzierter Lebensqualität
    E.2.2Secondary objectives of the trial
    Gaining first insights into the effects of pre-, peri- and postoperative
    cannabinoid intake on the physical and psychological coping with surgery
    as well as on the pain perception of patients with severely reduced quality of
    life
    Gewinnung erster Erkenntnisse über die Auswirkungen einer prä-, peri- und postoperativen Cannabinoid-Einnahme auf die physische und psychische Operationsbewältigung sowie das Schmerzempfinden von Patienten mit stark reduzierter Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Indication for a spinal fusion surgery
    • Suspected availability within the max.120 day period of study participation
    • No identification of any exclusion criterion
    • Schriftliche Dokumentation der Einwilligung zur Prüfungsteilnahme nach vorhergehender ausreichender schriftlicher und mündlicher Information
    • Indikationsstellung für eine stabilisierende Wirbelsäulenoperation (Eingriff in 14 bis 28 Tagen)
    • Voraussichtliche Verfügbarkeit innerhalb des max. 120-tägigen Studienzeitraums (ambulante und stationäre Betreuung)
    • Kein Zutreffen eines Ausschlusskriteriums
    E.4Principal exclusion criteria
    1) Non-completion of the 18th year of life
    2) Detention (for a court or administrative order), accommodation
    (under Unterbringungsgesetz) or (already made or in the) appointment
    of a trustee
    3) Limited contractual capability
    4) Military service
    5) Pregnancy and not excluded pregnancy (women of childbearing
    potential)
    6) Risk of the occurrence of pregnancy during the study participation (in
    women the absence of at least one of the following criteria: onset of
    menopause more than 2 years ago, postmenopausal sterilization,
    surgical sterilization, use of a reliable method of contraception for the duration of the study with hormones, intrauterine device (coil) or diaphragm / condom + spermicide)
    7) Lactation
    8) HADS-Anxiety> 8
    9) HADS-Depression> 8
    10) Treatment with a cannabinoid or consumption of cannabis or analogous substances within the past 6 months
    11) Contraindication for nabilone
    12) Start of opioid therapy in the last week
    13) (except for the investigational drug:) Foreseeable treatment with cannabinoids or consumption of cannabis or analogous substances during study participation
    14) Absolute contraindication for the use of postoperative medication required to be applied (Mexalen®, Tradolan®, Dipidolor® and Zofran
    Zydis®)
    15) Unsatisfactory treatability of pain resulting from multiple contraindications for the use of analgesics and analgesics classes
    16) Foreseeable compliance problems
    17) Concomitant disease with the potential for a relevant short-term improvement or worsening of pain and mental state
    18) Participation in another study with insurance cover
    19) Running processes for early retirement / long-term sick leave
    20) (Except for the surgery-related hospitalization:) planned hospital stay within the next four months (incl. stays preceding surgery at other Departments of the Orthopedic Hospital Speising)
    • Nichtvollendung des 18. Lebensjahres
    • Anhaltung (auf gerichtliche oder behördliche Anordnung), Unterbringung (gemäß Unterbringungsgesetz) oder (bereits erfolgte oder eingeleitete) Bestellung eines Sachwalters
    • Nicht-Geschäftsfähigkeit
    • Präsenzdienst
    • Schwangerschaft und Nichtausschluss einer Schwangerschaft (bei gebärfähigen Frauen)
    • Risiko des Eintretens einer Schwangerschaft während der Prüfungsteilnahme (bei Frauen Nichtvorliegen von zumindest einem der folgenden Kriterien: Eintritt der Menopause vor mehr als 2 Jahren, postmenopausale Sterilisation, chirurgische Sterilisation, Zusage für eine Kontrazeption während der Studienintegration mit Hormonen, Spirale oder Diaphragma/Kondom+Spermizid)
    • Stillperiode
    • HADS-Angst > 8
    • HADS-Depression > 8
    • Behandlung mit einem Cannabinoid oder Konsumation von Cannabis oder analogen Substanzen innerhalb der letzten 6 Monate
    • Kontraindikation für die Einnahme des Cannabinoids Nabilon
    • Beginn einer Schmerztherapie mit Opiaten in der letzten Woche
    • (Mit Ausnahme des Prüfpräparats:) Absehbare Behandlung mit Cannabinoiden oder Konsumation von Cannabis oder analogen Substanzen während der Prüfungsteilnahme
    • Absolute Kontraindikation für die Anwendung der postoperativ obligatorisch anzuwendenden Medikation (Mexalen®, Tradolan®, Dipidolor® und Zofran Zydis®)
    • Unzufriedenstellende Behandelbarkeit des Schmerzes aufgrund einer Häufung von Kontraindikationen für die Anwendung von Analgetika und Analgetikaklassen
    • Absehbare Complianceprobleme
    • Begleiterkrankung mit dem Potenzial für eine relevante kurzfristige Verbesserung oder Verschlechterung der Schmerz- und Befindenssymptomatik
    • Teilnahme an einer anderen Studie mit Versicherungsschutz
    • Laufendes Verfahren zu frühzeitiger Pensionierung/Langzeit-Krankenstand
    • (Mit Ausnahme der operationsbedingten stationären Aufnahme:) Innerhalb der nächsten 4 Monate geplanter stationärer Aufenthalt (inkl. präoperativ vorgeschaltete Aufenthalte an Abteilungen des Orthopädischen Spitals Speising)
    E.5 End points
    E.5.1Primary end point(s)
    Prior-ranking endpoints:
    • Change in HADS anxiety (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in HADS depression (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in SF36 mental sum score (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in SF36 physical sum score (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in Oswestry Disability Questionnaire Low Back Pain (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in FABQ (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in FABQ-subscore work (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in FABQ-subscore physical activity (U1 to U2, U1 to U7, U1 to U8) [-]
    • Change in pinprick pain threshold (U1 to U2, U1 to U3, U1 to U5, U1 to U7, U1 to U8) [mN]
    Vorrangige Zielparameter:
    • Veränderung HADS-Angst (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung HADS-Depression (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung SF36 Psychischer Summenscore (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung SF36 Körperlicher Summenscore (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung Oswestry Low Back Pain Disability Questionnaire (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung FABQ (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung FABQ-Subscore Arbeit (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung FABQ-Subscore physische Aktivität (U1 bis U2, U1 bis U7, U1 bis U8) [-]
    • Veränderung Pinprick-Schmerzschwellenwert (U1 bis U2, U1 bis U3, U1 bis U5, U1 bis U7, U1 bis U8) [mN]
    E.5.1.1Timepoint(s) of evaluation of this end point
    U1 = First examination in the morning of the surgery preparation day
    U2 = Examination in the morning of the day before the surgery
    U3 = Examination in the morning of postop. day 2
    U4 = Examination in the morning of postop. day 5
    U5 = Examination in the morning of dismissal day (not before postop. day 6)
    U6 = Examination (telephone call) in the morning of postop. day 21
    U7 = Examination in the morning of postop. day 42
    U8 = Last examination in the morning of postop. day 84
    U1 = Eingangsuntersuchung (Patienteneinschluss) am Morgen/Vormittag bei Vorstellung in OPV°
    U2 = Untersuchung am Morgen/Vormittag des Tags vor der OP
    U3 = Untersuchung am Morgen/Vormittag von postop. Tag 2
    U4 = Untersuchung am Morgen/Vormittag von postop. Tag 5
    U5 = Untersuchung am Morgen/Vormittag des Entlassungstags (ab postop. Tag 6)
    U6 = Untersuchung (telefonische Kontaktierung) am Morgen/Vormittag von postop. Tag 21
    U7 = Untersuchung am Morgen/Vormittag von postop. Tag 42
    U8 = Abschlussuntersuchung (Prüfungsteilnahmebeendigung) am Morgen/Vormittag von postop. Tag 84
    E.5.2Secondary end point(s)
    further selected endpoints:
    • HADS anxiety at U2, U7 and U8) [-]
    • HADS depression at U2, U7 and U8) [-]
    • SF36 mental sum score at U2, U7 and U8) [-]
    • SF36 physical sum score at U2, U7 and U8) [-]
    • Oswestry Disability Questionnaire Low Back Pain at U2, U7 and U8) [-]
    • FABQ at U2, U7 and U8) [-]
    • FABQ-subscore work at U2, U7 and U8) [-]
    • FABQ-subscore physical activity at U2, U7 and U8) [-]
    • Pinprick pain threshold at U2, U3, U4, U5, U7 and U8 [mN]
    • analgesics consumption from end of surgery until U4, from end of surgery until U5, from U5 until U7 and from U5 until U8 [<standard / standard /> standard]
    • duration of hospitalization [days]
    • ICU length of stay [days]
    • Items 1-n of the questionnaire on personal attitude at U7
    weitere ausgewählte Zielparameter:
    • HADS-Angst zu U2, zu U7 und zu U8 [-]
    • HADS-Depression zu U2, zu U7 und zu U8 [-]
    • SF36 Psychischer Summenscore zu U2, zu U7 und zu U8 [-]
    • SF36 Körperlicher Summenscore zu U2, zu U7 und zu U8 [-]
    • Oswestry Low Back Pain Disability Questionnaire zu U2, zu U7 und zu U8 [-]
    • FABQ zu U2, zu U7 und zu U8 [-]
    • FABQ-Subscore Arbeit zu U2, zu U7 und zu U8 [-]
    • FABQ-Subscore physische Aktivität zu U2, zu U7 und zu U8 [-]
    • Pinprick-Schmerzschwellenwert zu U2, zu U3, zu U4, zu U5, zu U7 und zu U8 [mN]
    ´• Schmerzmittelverbrauch von OP-Ende bis U4, von OP-Ende bis U5, von U5 bis U7 und von U5 bis U8 [<Standard/Standard/>Standard]
    • Krankenhausaufenthaltsdauer [Tage]
    • ICU-Liegedauer [Tage]
    • Items 1-n des Fragebogens zu persönlichen Einstellungen zu U7
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E 5.1.1
    siehe E 5.1.1
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 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 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state36
    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)
    none
    keine
    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 Decision2016-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-20
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