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    Summary
    EudraCT Number:2009-017472-25
    Sponsor's Protocol Code Number:DKKS_09_2009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-01-20
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017472-25
    A.3Full title of the trial
    „Duplex-kontrollierte, katheter-gestützte Schaumsklerosierung (DKKS) von Krampfadern in Kombination mit Tumeszenzlösungsapplikation (TLA)“

    (“Catheter-directed foam sclerotherapy of varicose veins under tumescent local application ”)
    A.3.2Name or abbreviated title of the trial where available
    DKKS_TLA_2009
    A.4.1Sponsor's protocol code numberDKKS_09_2009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Schleswig-Holstein, Campus Lübeck
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Aethoxysklerol® 2%
    D.2.1.1.2Name of the Marketing Authorisation holderChemische Fabrik Kreussler & Co. GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAethoxysklerol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLIDOCANOL
    D.3.9.1CAS number 3055990
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 to 2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAethoxysklerol ist ein Sklerosierungsmittel auf der Basis von Macrogollaurylether (Polidocanol)
    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 Yes
    D.2.1.1.1Trade name Natriumchlorid-Infusionslösung 9mg/ml (0,9 %)
    D.2.1.1.2Name of the Marketing Authorisation holderBerlin-Chemie AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNatriumchlorid 9mg/ml
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    Infiltration use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erwachsene mit einer Stammvarikose der V. saphena magna, bei der die medizinische Indikation zur operativen Sanierung vorliegt.

    I83.9, I83.1, I83.2
    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
    Evaluierung der Verschlussraten der V. saphena magna 3 cm und 30 cm distal der sapheno-femoralen Mündung 12 Monate nach Behandlung mit duplex-kontrollierter, kathetergestützter Schaumsklerosierung (DKKS) und Tumeszenzlösungsapplikation (TLA).
    E.2.2Secondary objectives of the trial
    Erhebung der Daten Patientenzufriedenheit, Schmerzen und venöse Abpumpleistung (Wiederauffüllzeit).
    Deskriptiver Vergleich der Verschlussraten von Stammvarizen nach DKKS mit und ohne TLA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Einverständnis zur Prüfungsteilnahme und Datenschutzerklärung unterschrieben
    • Frauen und Männer im Alter von 18-89 Jahren mit einer Stammvarikose der V. saphena magna, bei denen die medizinische Indikation zur Schaumsklerosierungstherapie besteht
    • Diameter der V. saphena magna zwischen 5 und 10 mm, gemessen 3 cm distal der sapheno-femoralen Mündung
    • Tiefes Venensystem frei durchgängig
    E.4Principal exclusion criteria
    • Symptomatisches persistierendes Foramen ovale
    • bekannte Überempfindlichkeit gegen einen oder mehrere arzneilich wirksame(n) Bestandteile der Prüfmedikation
    • bestehende Schwangerschaft
    • Knöchel-Arm Index <0.9
    • schwere kardiovaskuläre Erkrankung
    • fieberhaften Zuständen
    • entzündlichen Hauterkrankungen im Behandlungsareal
    • Symptome einer Mikroangiopathie oder Neuropathie
    • sehr schlechter Allgemeinzustand
    • Bronchialasthma oder bekannter starker Neigung zu Allergien
    • Patienten mit akut thromboembolischen Erkrankungen
    • Patienten mit hohem Thromboserisiko (> 3 der folgenden Kriterien):
    • Einnahme von hormonalen Kontrazeptiva
    • hormonale Ersatztherapie
    • Adipositas
    • Rauchen
    • länger andauernde Phasen von Immobilität

    • Allgemeine Ausschlusskriterien: schwere organische, neurologische, psychiatrische Erkrankung, parallele Teilnahme an einer anderen klinischen Prüfung, bekannte oder vermutete Unfähigkeit, die Bedingungen des Prüfplans einzuhalten (z.B. kein fester Wohnsitz, früherer oder (und) aktueller Medikamentenmissbrauch, Alkoholabusus, gesetzliche Entmündigung und/oder andere Umstände, die dazu führen, dass der Patient Art, Zielsetzung und mögliche Auswirkungen der klinischen Studie nicht versteht, Patienten, die auf gerichtliche oder amtliche Anordnung unter Haft stehen, Anzeichen für nicht kooperatives Verhalten, Patienten, die sprachliche Schwierigkeiten haben, die Patienteninformation zu verstehen.
    E.5 End points
    E.5.1Primary end point(s)
    • Vollständige Okklusion der V. saphena magna 3 cm und 30 cm distal der sapheno-femoralen Mündung 12 Monate nach Behandlung mit duplex-kontrollierter, kathetergestützter Schaumsklerosierung (DKKS) und Tumeszenzlösungsapplikation (TLA)
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Therapieoptimierungsstudie, Verbesserung des Outcomes
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    DKKS mit und ohne TLA
    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 Information not present in EudraCT
    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
    Ende der Studie 12 Monate nach Visite 1 (Behandlung)
    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 months0
    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 months0
    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.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.1.3Elderly (>=65 years) Yes
    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 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 state30
    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)
    Die Probanden werden vor der Studie von einem Haus- oder Hautarzt betreut; während der Studie werden die Probanden durch den Prüfarzt betreut; nach der Studie erfolgen jährliche klinische, phlebologische Kontrollen. Zusätzlich gehen die Probanden in die Betreuung vor der Studie zurück.
    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 Decision2010-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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