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    Summary
    EudraCT Number:2012-002406-46
    Sponsor's Protocol Code Number:13.06.2012
    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:2012-09-07
    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 number2012-002406-46
    A.3Full title of the trial
    Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaicin
    Dichte der epidermalen Nervenfasern (ENF) nach unterschiedlicher Expositionsdauer mit hoch- und niedrigdosiertem topischem Capsaicin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of different Capsaicin doses and their effects on nerve fibres in the skin
    Vergleich unterschiedlicher Capsaicin Dosierungen und ihr Einfluss auf die Nervenfasern in der Haut
    A.3.2Name or abbreviated title of the trial where available
    Capsaicin dose and reduction of ENF density
    Capsaicin Dosis und Reduktion der ENF-Dichte
    A.4.1Sponsor's protocol code number13.06.2012
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    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 supportMedizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien
    B.5.2Functional name of contact pointUniversitätsklinik für Anästhesie
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404004108
    B.5.5Fax number00431404004110
    B.5.6E-mailjoerg.hiesmayr@meduniwien.ac.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 Qutenza
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameQutenza
    D.3.2Product code N01BX04
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapsaicin
    D.3.9.1CAS number 404-86-4
    D.3.9.2Current sponsor codeNGX 4010
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number179
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 No
    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.3.1Product nameCapsaicin 0,05% Ointment
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapsaicin
    D.3.9.1CAS number 404-86-4
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number179
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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
    Impact of Capsaicin on epidermal nerve fibres
    Einfluss von Capsaicin auf epidermale Nervenfasern
    E.1.1.1Medical condition in easily understood language
    Impact of Capsaicin on nerve fibres in the skin
    Einfluss von Capsaicin auf Nervenfasern in der Haut
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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
    Comparison of different Capsaicin doses on the density of epidermal nerve fibres
    Vergleich unterschiedlicher Capsaicin Dosierungen auf die Dichte der epidermalen Nervenfasern
    E.2.2Secondary objectives of the trial
    Comparison of different Capsaicin doses on the density of epidermal nerve fibres,
    impact of gender
    Vergleich unterschiedlicher Capsaicin Dosierungen auf die Dichte der epidermalen Nervenfasern, Einfluss des Geschlechtes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    healthy volunteers
    18 > age < 80
    Gesunde ProbandInnen
    Alter 18-80 Jahre
    E.4Principal exclusion criteria
    anamnestic injury or surgery of the thighs
    Nerved damage (Nervus femoralis or lumbal nerval roots 2-4)

    lack or different information by testing of sensitivity disturbance, impaired experience of pain and temperature in the area of the fore side of the thighs
    prior use of Qutenza or other topical capsaicin preparations in the area of the firesides of the thighs in between 3 months prior to the start of the investigation

    known hypersensitivity to capsaicin

    known hypersensitivity to local anesthetic ointment Emla- Creme® (Lidocaine, Prilocaine, Macrogolglycerolhydroxystearat, Carbomer)

    known hypersensitivity to Ultrasicc® (Petrolatum, Cera Microcristallina, Stearylalkohol, Macrogolstearat 2000, Polyacrylacid, Natriumedetat, Propyl-4-hydroxybenzoat) as carrier substance of the Capsaicin 0,05% Creme

    known hypersensitivity to Qutenza cleansing gel (Macrogol 300, Carbomer 1382, Natriumedetat, Butylhydroxyanisol)
    known hypersensitivity to paracetamol

    unstable hypertension, current cardiovascular event, methaemoglobinaemia, G6PDH-Insufficiency, hepatic insufficiency, use if antiarrhythmics, known alcohol or drug abuse

    participation in another trial

    Pregnancy or breast feeding
    • Anamnestische Verletzung oder operative Eingriffe an den Oberschenkeln
    • Anamnestische Schädigungen des N. femoralis oder der Nervenwurzeln L2-L4
    • Fehlende oder unterschiedliche Angaben bei der Prüfung von Berührungssensibilität, Schmerzempfindung und Temperaturempfindung im Bereich beider Oberschenkelvorderseiten
    • Anamnestische Vorbehandlung mit Qutenza® oder anderen topischen Capsaicinzubereitungen im Bereich der Oberschenkelvorderseiten während der vergangenen 3 Monate vor Studienbeginn
    • Bekannte Überempfindlichkeit gegen den Wirkstoff bzw. sonstige Bestandteile von Emla- Creme® (Lidocain, Prilocain, Macrogolglycerolhydroxystearat, Carbomer), Ultrasicc® (Petrolatum, Cera Microcristallina, Stearylalkohol, Macrogolstearat 2000, Polyacrylsäure, Natriumedetat, Propyl-4-hydroxybenzoat) als Salbengrundlage der Capsaicin 0,05% Creme, Qutenza® (Capsaicin, Silikonklebstoffe, Diethylenglycolmonoethylether, Dimeticon, Ethylcellulose) oder das Reinigungsgel (Macrogol 300, Carbomer 1382, Natriumedetat, Butylhydroxyanisol)
    • Bekannte Überempfindlichkeit gegen Paracetamol.
    • Instabile oder schlecht eingestellte Hypertonie oder kürzliche kardiovaskuläre Ereignisse, Methämoglobinämie, Glukose-6-phosphat-Dehydrogenasemangel, Leberinsuffizienz, Einnahme von Antiarrhythmika. Bekannter Alkohol- und/oder Opioidabusus
    • Teilnahme an einer anderen Arzneimittelstudie
    • Schwangerschaft, Stillende Mütter
    E.5 End points
    E.5.1Primary end point(s)
    epidermal nerve fibre density
    epidermale Nervenfaser-Dichte
    E.5.1.1Timepoint(s) of evaluation of this end point
    0, 30, 45, 60, 90, 120 mins.
    0, 30, 45, 60, 90, 120 Minuten
    E.5.2Secondary end point(s)
    not applicable
    nicht zutreffend
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    nicht zutreffend
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    untersucher-verblindet
    observer-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    letzter Besuch des/der letzten Proband/in
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    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 Decision2012-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-03
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