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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005645-27
    Sponsor's Protocol Code Number:DBM
    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:2009-05-18
    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 number2008-005645-27
    A.3Full title of the trial
    Vergleich von demineralisierter Knochenmatrix (DBM) und Knochenallograft bei der anterioren lumbale Wirbelkörperfusion (ALIF) mittels Synfix LR
    A.3.2Name or abbreviated title of the trial where available
    DBM Studie
    A.4.1Sponsor's protocol code numberDBM
    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 SponsorMedizinische Universität Innsbruck, vertreten durch Univ. Prof. Dr. Martin Krismer
    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 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 Demineralisierte Human-Knochenmatrix, gefriergetrocknet, DIZG
    D.2.1.1.2Name of the Marketing Authorisation holderDeutsches Institut für Zell- und Gewebeersatz gGmbH
    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 nameDemineralisierte Human-Knochenmatrix, gefriergetrocknet, DIZG
    D.3.2Product code PEI.H.03358.01.1
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPImplant use
    Parenteral use (Noncurrent)
    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) 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
    Anteriore lumbale Wirbelkörperfusion (Anterior lumbar interbody fusion, ALIF) ist ein Standardverfahren bei der operative Behandlung von chronischem Kreuzschmerz und zur Fusion bei degenerativen Bandscheibenveränderungen (degenerative disc disease, DDD).
    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
    Vergleich der Fusionsrate 1 Jahr nach ALIF im Vergleich demineralisierter Knochenmatrix (DBM) versus autologem Knochen. Evaluation mittels Computertomografie
    E.2.2Secondary objectives of the trial
    Feststellen der Verbesserung von Schmerz (mittels Visual Analogue Scale (VAS)), und subjektivem Outcome (Oswestry Disability Score) zwischen prä- und postoperativen Zustand
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patienten, die aufgrund chronischer Kreuzschmerzen, verursacht durch eine Degeneration von 1-2 Bandscheiben zwischen L4 und S1 über 6 Monate erfolglos konservativ therapiert wurden und bei welchen eine ALIF geplant ist
    2) Personen, die den prinzipiellen Kriterien der Studie entsprechen (Verfügbarkeit während des Untersuchungszeitraumes, kein Vorliegen eines Ausschlußkriteriums).
    3) Personen zwischen 20 und 65 Jahren
    E.4Principal exclusion criteria
    1) Personen mit malignen oder infektiösen Erkrankungen, mit Z.n. Pulmaonalembolie oder Pneumonie, verminderter Knochendichte, aktiven Infektionen, Diabetes Mellitus oder Stoffwechselerkrankungen, welche das Skelettsystem betreffen.
    2) Personen mit vorausgehenden Wirbelsäulenfusionsoperation
    3) Patienten mit Revisionsoperation bzw. mit Pseudarthrose
    4) Patienten mit Erkrankungen, welche die gesamte Wirbelsäule betreffen
    5) Stillende Mütter.
    6) Schwangere oder Frauen unter 50 Jahren, bei denen das Vorliegen einer Schwangerschaft vor Beginn der Studie durch den verantwortlichen Arzt nicht ausgeschlossen worden ist. Frauen unter 50 Jahre werden hinsichtlich der Verwendung einer verläßlichen Kontrazeption (z.B. Pille, IUD) befragt, bei Unklarheiten während des Studienzeitraumes werden Schwangerschaftstests monatlich durchgeführt.
    7) Wehrpflichtige, die den Präsenzdienst leisten.
    8) Personen, die auf gerichtliche oder behördliche Anordnung angehalten oder gemäß dem Unterbringungsgesetz untergebracht sind, oder für die ein Sachwalter bestellt ist.
    10) Personen mit verminderter Urteilsfähigkeit.
    11) Personen die an einer anderen klinischen Studie teilnehmen.
    12) Starke Raucher (>10 Zigaretten/Tag)
    E.5 End points
    E.5.1Primary end point(s)
    Abschlußuntersuchung klinisch und computertomografisch 1 Jahr nach Operation
    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 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) 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 Yes
    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
    autologer Knochen
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    l
    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.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    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 state50
    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 Decision2009-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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