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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2007-007794-23
    Sponsor's Protocol Code Number:PAINLESS
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-23
    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 - PEI
    A.2EudraCT number2007-007794-23
    A.3Full title of the trial
    Prospektive, doppelblinde, randomisierte, Plazebo-kontrollierte Cross-over Studie zur Wirkung von intravenösen Immunglobulinen bei komplex-regionalem Schmerzsyndrom Typ I (M. Sudeck)
    A.3.2Name or abbreviated title of the trial where available
    Painless
    A.4.1Sponsor's protocol code numberPAINLESS
    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 SponsorJustus-Liebig-University
    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 Gamunex 10% zur Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderTalecris Biotherapeutics
    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 Intravenous infusion
    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.3.9.1CAS number 8000012671
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN HUMAN NORMAL
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    complex-regional pain syndrome type 1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064334
    E.1.2Term Complex regional pain syndrome Type I
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduktion des Impairment Level SumScore (ISS) um mehr als 50% (Oerlemans, Goris et al. 1998)

    Der ISS setzt sich zusammen aus 5 Items:
    • Visuelle Analogskala (VAS)
    • McGill Pain Questionnaire
    • Differenz der Hauttemperatur zwischen betroffener und nicht betroffener Seite
    • Differenz des Hand- bzw. Fußvolumens (Ödem) betroffene vs. nicht betroffene Seite
    • Differenz des aktiven Bewegungsumfanges von insgesamt 5 Gelenken

    Die Rohdaten der einzelnen Items werden in eine Skala von 1-10 transformiert, so dass der Score eine Punktzahl von 5– 50 annehmen kann.
    Der Hauptzielparameter wird zu Beginn und am Ende, d.h. nach 3 Monaten, der Phase I, und zu Beginn und am Ende der Phase II bestimmt. Der Behandlungserfolg innerhalb der beiden Phasen wird durch die Differenz des ISS am Beginn und am Ende beschrieben, d.h. ΔISS = ISSBeginn – ISSEnde.
    E.2.2Secondary objectives of the trial
    • Pain disability score
    • begleitende Schmerzmedikation bzw. der Anzahl notwendiger Sympathikusblockaden
    • Titer antineuronalen Autoantikörper im Serum
    • Verbesserung der Lebensqualität (SF-36)
    • Konzentration B-Zell-aktivierender Faktoren (BAFF / APRIL) im Serum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Schriftliche Einverständniserklärung („informed consent“)
    • Alter mindestens 18 und höchstens 80 Jahre
    • Diagnose eines CRPS I nach den IASP Kriterien (Harden, Bruehl et al. 2007)
    s. Kapitel 5.3.4
    • Hauttemperatur an der betroffenen Extremität gleich oder wärmer als die Gegenseite
    E.4Principal exclusion criteria
    • Immunsuppressive Therapie in den letzten 3 Monaten
    • Selektiver IgA-Mangel
    • Schwere Herzerkrankung in der Anamnese (z.B. instabile Angina pectoris, Herzinfarkt innerhalb eines Jahres vor Studieneinschluss, Kardiomyopathie, Herzinsuffizienz schwerer als NYHA-Stadium II, implantierter Defibrillator, Z.n. Herzstillstand)
    • Tumorerkrankung in den letzten 5 Jahren in der Anamnese
    • Allergie gegen einen oder mehrere Bestandteile der Prüfsubstanz
    • Niereninsuffizienz > Grad 2
    • Teilnahme an einer anderen klinischen Studie oder < 3 Monate nach Beendigung einer vorangegangenen Studie
    • Impfung mit Lebendimpfstoff in den letzten 3 Monaten
    E.5 End points
    E.5.1Primary end point(s)
    Der primäre Zielparameter zur Beschreibung des Therapieerfolgs ist der „Impairment Level SumScore“ (ISS) (Oerlemans, Goris et al. 1998). Der ISS setzt sich zusammen aus 5 Items:
    • Visuelle Analogskala (VAS) beurteilt für Schmerz bei Anstrengung
    • McGill Pain Questionnaire (Anzahl der Worte, die von einer Liste von Adjektiven gewählt werden)
    • Differenz der Hauttemperatur zwischen betroffener und nicht betroffener Seite
    • Differenz des Hand- bzw. Fußvolumens (Ödem) betroffene vs. nicht betroffene Seite
    • Differenz des aktiven Bewegungsumfanges von insgesamt 5 Gelenken
    Die Rohdaten der einzelnen Items werden in eine Skala von 1-10 transformiert, so dass der Score eine Punktzahl von 5 (wenig Symptome) – 50 (starke Symptome) annehmen kann.
    Der Hauptzielparameter wird zu Beginn und am Ende, d.h. nach 3 Monaten, der Phase I, und zu Beginn und am Ende der Phase II bestimmt. Der Behandlungserfolg innerhalb der beiden Phasen wird durch die Differenz des ISS am Beginn und am Ende beschrieben, d.h. ΔISS = ISSBeginn – ISSEnde.
    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 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 No
    E.8.1.6Cross over Yes
    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.8.3 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
    letzte visite des letzten Patienten ist identisch mit Ende der Studie.
    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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    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)
    Nach Abschluss der Studie werden die Patienten weiter entsprechend internationaler Standards und Leitlinien symptomatisch behandelt (multimodale Schmerztherapie und Physiotherapie).
    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 Decision2009-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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