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    Summary
    EudraCT Number:2011-004393-28
    Sponsor's Protocol Code Number:06-2011
    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:2011-12-09
    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 number2011-004393-28
    A.3Full title of the trial
    "Effectiveness of leech therapy in treatment of chronic low back pain -
    a randomised controlled clinical study"
    „Randomisierte kontrollierte Studie zur Wirksamkeit der Blutegeltherapie (Hirudo verbana) bei chronischen unteren Rückenschmerzen (low back pain)“



    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectives of leech therapy
    Wirksamkeit der Blutegeltherapie
    A.4.1Sponsor's protocol code number06-2011
    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 SponsorCharité - Universitätsmedizin Berlin
    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 supportKarl und Veronika Carstens Stiftung Essen
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBiebertaler Blutegelzucht
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointAbteilung für Naturheilkunde
    B.5.3 Address:
    B.5.3.1Street AddressKönigstr. 63
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14109
    B.5.3.4CountryGermany
    B.5.4Telephone number493080505691
    B.5.5Fax number493080505691
    B.5.6E-mailnaturheilkunde@immanauel.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Medirud®Biebertal
    D.2.1.1.2Name of the Marketing Authorisation holderBiebertaler Blutegelzucht
    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 nameMedirud®Biebertal
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHirudo verbana
    D.3.9.2Current sponsor code06-2011
    D.3.9.3Other descriptive nameHirudo verbana
    D.3.9.4EV Substance CodeSUB14106MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 7
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeLiving animal (leech)
    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
    chronic low back pain

    -diagnosis assured by specialist (orthopedy, neurology, pain therapy) as chronic low back pain for at least 3 month caused by nonspecific lumbar syndrome

    - averaged pain intensity during the last 3 month of at least 40mm measured by VAS (visual analog scale) during pain periods
    on 4 out of 7 days a week
    Chronische untere Rückenschmerzen

    -vorbestehende und fachärztlich (Orthopädie, Neurologie, Schmerztherapie) gesicherte Diagnose eines chronischen unspezifischen LWS-Syndroms seit mindestens 3 Monaten

    -durchschnittliche initiale Schmerzintensität in Schmerzphasen mit Stärke >40 mm auf der VAS von 0 bis 100 mm und Schmerzen an mindestens 4 von 7 Wochentagen in den letzten 3 Monaten als Ausgangswert
    E.1.1.1Medical condition in easily understood language
    chronic low back pain, since at least 3 months
    Chronischer unterer Rückenschmerz, welcher seit mindestens 3 Monaten besteht.
    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
    Changes in the VAS (100mm) pain score 7 days after leech treatment
    Veränderungen des VAS (100 mm)Schmerzscore nach 7 ±1Tagen
    E.2.2Secondary objectives of the trial
    -100mm VAS concerning back pain after 56 +-5 days
    -100 mm VAS concerning global disability caused by back pain
    -Roland Morris Disability Score
    -FFbH-R
    -SF-36
    -general assesment of patient antiception concerning the efforts of the therapy (Likert-scale)
    -CES-D
    -SES
    -diary of analgetics consumption
    -checking agreability by asking for serious adverse events (SAEs)
    -100mm VAS Schmerzscore nach 56 +-5 Tagen
    -100 mm VAS für die durchschnittliche globale Beeinträchtigung durch Rückenschmerzen während der vergangenen Woche
    -Roland Morris Disability Score
    -Funktionsfragebogen Rückenschmerz (FFbH-R)
    -Erhebung des allgemeinen Gesundheitszustandes mittels SF36
    -Gesamteinschätzung der Wirksamkeit und Verträglichkeit (Likert Skala) von Seiten des Patienten
    -CES-D Depressionsskala
    -Affektive Schmerzbewertung (SES)
    -Intensität/Frequenz analgetische Dauer- und Bedarfsmedikation (Tagebuch)
    -Verträglichkeit anhand der Abfrage unerwünschter Ereignisse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -male and femal patient from 18 to 70 years old
    -existing, specialised physician (orthopedics, neurology, pain treatment) prooved diagnosis of chronic low back pain caused by nonspecific lumbar syndrome
    - averaged pain intensity during the last 3 month of at least 40mm measured by VAS (visual analog scale) during pain periods
    on 4 out of 7 days a week
    -Männliche und weibliche Patienten im Alter von 18 bis 70 Jahren
    -vorbestehende und fachärztlich (Orthopädie, Neurologie, Schmerztherapie) gesicherte Diagnose eines chronischen unspezifischen LWS-Syndroms seit mindestens 3 Monaten
    -durchschnittliche initiale Schmerzintensität in Schmerzphasen mit Stärke >40 mm auf der VAS von 0 bis 100 mm und Schmerzen an mindestens 4 von 7 Wochentagen in den letzten 3 Monaten als Ausgangswert
    E.4Principal exclusion criteria
    -anticoagulative treatment
    -anemia (Hgb in screening-lab below 12.2 g/dl bzw. 7.6 mmol/l (women); 14.0 g/dl bzw. 8.7 mmol/l (men)
    -anmenestic or laboratoric tested clotting disorder (Quick <70%, apTT >36 sec, TZ >21 sec)
    -invasive spine treatment including cortocoid injection up to 6 weeks ago or sheduled for the following 8 weeks
    -acute hernial disc
    -congenital spine disorders
    -known pregnancy
    -therapy by opioid-analgetics
    -insulin-dependent diabetes type 1
    -systemic medication by corticoids or immunisuppressives
    -acute psychotic disorders
    -serious comorbidity

    - Antikoagulation oder Hämophilie
    - Anämie (Hb im Screening-Labor unter 12.2 g/dl bzw. 7.6 mmol/l (Frauen); 14.0 g/dl bzw. 8.7 mmol/l (Männer)
    - Anamnestisch oder laborapparativ Gerinnungsstörung (Quick <70%, apTT >36 sec, TZ >21 sec)
    - Invasive Behandlungen incl. Kortikoid-Injektionen an der Wirbelsäule innerhalb der letzten 6 Wochen oder geplant innerhalb der nächsten 8 Wochen
    - Akuter Bandscheibenvorfall (Diagnose innerhalb der letzten 3 Monate)
    - Vorbekannte angeborene Fehlbildungen der LWS
    - Vorbekannte Schwangerschaft
    - Schmerzmedikation mit Opoid-Analgetika
    - Bekannter insulinpflichtiger Diabetes mellitus Typ I
    - Systemische Medikation mit Kortikoiden oder Immunsuppressiva
    - Akute psychotische Erkrankungen
    - Schwere Komorbidität
    E.5 End points
    E.5.1Primary end point(s)
    Change in pain intensity on the VAS from baseline to day 7 +-1
    Veränderung der Schmerzintensität auf der VAS nach 7 +- Tagen
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 +- 1 day
    7 +- 1 Tag
    E.5.2Secondary end point(s)
    Changes in values of function, pain, mood, quality of life assement inventories such as Rolland-Morris, SF 36 and others
    Funktion, Schmerz, Stimmung und Lebensqualitäts-Fragebbögen
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 +-1 days an 56 +-5 days
    7 +- Tage und 56+-5
    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 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 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
    Rückenschule
    Back training group
    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 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
    LVLS
    Die Studie ist beendet wenn der 44. Teilnehmer die Studie durchlaufen hat oder der letzte verbleibende Studienteilnehmer diese als Drop-Out verlassen hat (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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 months6
    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.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-09. Yes
    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 state44
    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 diffenrences to regular chronic back pain treatment given.
    Keine Unterschiede zur regulären Behandlung von chronischen Rückenschmerzen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation KPW Garbsen
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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