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    Summary
    EudraCT Number:2016-002085-31
    Sponsor's Protocol Code Number:RAD-ON02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-11
    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 number2016-002085-31
    A.3Full title of the trial
    Determining the immunological and pain reducing effects of serial radon balneology in patients with musculoskeletal disorders.
    Bestimmung der immunologischen und Schmerz lindernden Wirkung von seriellen Radonbädern bei Patienten mit muskuloskelettalen Beschwerden.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determining the immunological and pain reducing effects of serial radon balneology in patients with musculoskeletal disorders.
    Bestimmung der immunologischen und Schmerz lindernden Wirkung von seriellen Radonbädern bei Patienten mit muskuloskelettalen Beschwerden.
    A.3.2Name or abbreviated title of the trial where available
    RAD-ON02
    RAD-ON02
    A.4.1Sponsor's protocol code numberRAD-ON02
    A.5.4Other Identifiers
    Name:German Clinical Trials RegisterNumber:DRKS00016019
    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 SponsorKurort Forschungsverein Bad Steben e.V.
    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 supportLandesamt für Gesundheit und Lebensmittelsicherheit Bayern (LGL)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportKurort Forschungsverein Bad Steben e.V.
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBayerisches Staatsbad Bad Steben GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMarket community Bad Steben
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKurort Forschungsverein Bad Steben e.V.
    B.5.2Functional name of contact pointTrial Information
    B.5.3 Address:
    B.5.3.1Street AddressBadstraße 26
    B.5.3.2Town/ cityBad Steben
    B.5.3.3Post code95138
    B.5.3.4CountryGermany
    B.5.4Telephone number+4992885500762
    B.5.5Fax number+4992885500762
    B.5.6E-mailinfo@dr-klein-badsteben.de
    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 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 nameRadon
    D.3.2Product code none
    D.3.4Pharmaceutical form Bath additive
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Respiratory use (Noncurrent)
    Cutaneous use
    Inhalation use
    Transdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnone
    D.3.9.1CAS number 14859-67-7
    D.3.9.2Current sponsor codeRAD-ON02
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/l becquerel(s)/litre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1200
    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 Yes
    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 typeNatural gas in ground water with low dose radioactivity
    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 placeboBath additive
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic degenerative spine and/or joint disorders with pain perception of at least 1 year and pain intensity on visual analogue scale ≥4
    Chronisch degenerative Wirbelsäulen- und Gelenkbeschwerden mit einer Schmerzdauer von mindestens 1 Jahr und einer Schmerzintensität nach Visueller-Analog-Skala ≥4
    E.1.1.1Medical condition in easily understood language
    Chronic degenerative spine and/or joint disorders with pain perception of at least 1 year and pain intensity on visual analogue scale ≥4
    Chronisch degenerative Wirbelsäulen- und Gelenkbeschwerden mit einer Schmerzdauer von mindestens 1 Jahr und einer Schmerzintensität nach Visueller-Analog-Skala ≥4
    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
    * Change of circulating immune cells of treated patients by deep immunophenotyping.
    Deep immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers. The analyses are conducted at time points before and after spa therapy: before therapy (day 0), end of first round of spa therapy (day 21), month 3 (day 111) and month 6 (day 201) after spa therapy. The intervention scheme is repeated at day 241 to enable a cross-over design. Theses analyses are also conducted after the second intervention (identical scheme as the first intervention, however, the randomized groups are changed) (day 262), month 3 (day 352) and month 6 (day 442) after second spa therapy.
    * Detection of the inflammatory and anti-inflammatory cytokines alterations in the sera of the patients.
    * Detection of inflammatory mediators in blood cells by analysis of transcriptional copy number (RNA)
    * Analyse von Immunzellhauptpopulationen (Granulozyten, Monozyten, NK-Zellen, dendritische Zellen, T- und B-Zellen) sowie Subpopulationen und Aktivierungsmarker derer, die sich in der RAD-ON01 Studie als durch Radon moduliert gezeigt hatten. Mit Hilfe der Mehrfarbendurchflusszytometrie können aus dem Vollblut der Patienten damit bis zu 34 Immunzell(sub)populationen sowie zusätzlich deren Aktivierungsstatus bestimmt werden. Insbesondere werden die für eine Entzündungsregulation besonders wirksamen regulatorischen T-Zellen erfasst, ebenso wie dendritischen Zellen und Subpopulationen daraus.
    * Analyse von entzündlich und anti-entzündlich wirkenden Zytokinen im Serum der Patienten. Aus einigen in vitro Ergebnissen wissen wir auch um eine Regulation von weiteren Zytokinen, die am Knochenstoffwechsel beteilig sind, weshalb diese Zytokine auch erfasst werden.
    * Analyse von entzündlichen Mediatoren in Blutzellen der Patienten auf transkriptioneller Ebene, d.h. aus isolierter RNA.
    E.2.2Secondary objectives of the trial
    * Erfassung von Schmerzparametern mittels Druckschmerzanalgometrie und ein vom Patienten eigenverantwortlich geführtes Analogskala-Schmerztagebuch.
    * Erfassung von Herz-Kreislaufparametern mit Langzeit-EKG und Pulswellen-Messungen.
    * Erfassung des oxid. Stress durch Bestimmung von Superoxid-Dismutase und des „Antioxidative Defense-Systems“.
    * Bestimmung der Strahlenwirkung durch biodosimetrische Methoden in Blut-Lymphozyten.
    * Bestimmung von Chromosomenabberationen in Blutlymphozyten.
    * Funktionelle Analysen an Blutlymphozyten.
    * Bestimmung des Fettstoffwechsels anhand zirkulierender Botenstoffe.
    * Erfassung von Schmerzparametern mittels VAS und Schmerzanamnese (Dauer, Häufigkeit, Maximum, Qualität und Auftreten der Schmerzen). Bestimmung von messbaren Schmerzindikatoren (Rotation, Kinn-Sternum Abstand, Schober Maß, Ott Maß Finger-Boden-Abstand) und des Gesundheitszustandes des Patienten mittels Funktionsfragebogen Hannover (FFbH-R) und Gesundheitsfragebogen (EQ5DL)
    * Detection of pain relieve by pressure point dolorimetric method and detailed anamnesis, as well as pain and drug diary.
    * Detection of cardiovascular data via long-term ECG
    * Analysis of the oxidative stress via detection of the superoxide-dismutase (SOD) and the „Antioxidative Defense-Systems“ (AODS)
    * Analysis of the impact of ionizing radiation on blood cells by biodosimetric methods
    * Analysis of chromosomal aberrations in blood lymphocytes
    * Functional analyses on blood lymphocytes
    * Detection of patients’ lipid metabolism via circulating messengers
    * Analysis of pain by visul analoge scale (VAS) and pain history (duration, frequency, maximal pain, grade, and onset). Determination of measurable pain indicators (free rotation, chin-sternum distance, Schober degree, Ott degree, and finger-floor distance) as well as health status by Funktionsfragebogen Hannover (FFbH-R) and helth questionaire (EQ5DL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) age between 40 and 75 years
    b) chronic degenerative spine and ankle pain
    c) pain Duration more than one year
    d) pain Intensity more than 4 on VAS (visual analog scale)
    e) highly effective contraception (PEARL Index < 1%)
    f) reachability of the patients for treatment and follow up (patients live near place of ambulant treatment)
    g) patients who are willing to cooperate
    h) elucidation of the trail purpose and informed consent
    i) patient was not included in any other trail before (at least 3 month) and during the trial
    a) Alter mindestens 40 Jahre, bis 75 Jahre
    b) Chronisch degenerative Wirbelsäulen- und Gelenkbeschwerden
    c) Schmerzdauer über mindestens 1 Jahr
    d) Schmerintensität VAS ≥4
    e) Effektive hocheffektive Kontrazeption (PEARL Index <1%)
    f) Erreichbarkeit der Patienten (geographische Nähe) für Behandlung und Follow-up
    g) Kooperationsbereitschaft der Patienten
    h) Durchgeführte Patientenaufklärung und schriftliche Einwilligung
    i) Keine Teilnahme an anderen Studien (3 Monate vor und) während der Teilnahme
    E.4Principal exclusion criteria
    a) Pregnant or nursing woman
    b) fertile patients who refuse effective contraception during study treatment
    c) heart failure > NYHA II or EF<40 %
    d) non-adjustable hypertonia > 180/90 mmHg
    e) cardiac arrhythmia LOWN-Kategorie > Iva
    f) patients with distinct constraints in cardiac capacity
    g) apparent and non-drug-adjustable hyperthyroidism
    h) acute and underlying wasting diseases
    i) patients with skin diseases, which are not allowed to have spa regimen
    j) last radon spa regimen less than 9 month before inclusion
    k) radiation therapy upon cancer treatment
    l) persistent drug and/or alcohol abuse
    m) patients not able or willing to behave according to study protocol
    n) patients how refuse the collection and the recording their personal and disease related date in an pseudonymized form
    o) concurrent participation at another trial or the time to the previously attended trial is shorter than the five-fold half-life of the IMP, minimum 60 days
    p) intolerance against the “Wellnessbad Latschenkiefer” or against a ingredient of the bath additive
    q) patients with extensive concomitant diseases
    r) patients where the investigator has significant objections against the participation, because patients’ welfare is in danger
    a) Schwangere oder stillende Frauen
    b) Gebär- bzw. zeugungsfähige Menschen, die nicht zu konsequenten Verhütungsmaßnahmen während der Therapie willens oder in der Lage sind
    c) Herzinsuffizienz > NYHA II oder EF<40 %
    d) Nicht einstellbare Hypertonie > 180/90 mmHg
    e) Herzrhythmusstörungen LOWN-Kategorie > IVa
    f) Patienten mit ausgeprägter Einschränkung der kardiovaskulären Belastbarkeit
    g) Manifeste, medikamentös nicht einstellbare Schilddrüsenüberfunktion
    h) Akute entzündliche oder konsumierende Prozesse
    i) Patienten mit Hauterkrankungen, bei denen eine Radon-Badekur kontraindiziert ist.
    j) Erfolgte Radonbehandlung innerhalb von 9 Monaten vor Studienbeginn
    k) Erfolgte Strahlentherapie im Zuge einer Tumorerkrankung
    l) Anhaltender Drogen-, Medikamenten- oder Alkoholmissbrauch
    m) Patienten, die nicht in der Lage oder bereit sind, sich protokollgerecht zu verhalten und behandeln zu lassen
    n) Fehlende Bereitschaft zur Speicherung und Weitergabe der persönlichen Krankheitsdaten im Rahmen des Protokolls
    o) Gleichzeitige Teilnahme an einer anderen klinischen Studie oder zeitlicher Abstand nach Ende der vorangegangen Studie kleiner als die fünffache Halbwertszeit des Prüfpräparates, mindestens aber 60 Tage.
    p) Unverträglichkeit gegenüber Wellnessbad Latschenkiefer oder einen dessen Inhaltsstoffe
    q) Patienten mit erheblichen Begleiterkrankungen
    r) Patienten, bei denen nach Einschätzung des Prüfers eine Teilnahme im Hinblick auf ihr Wohlergehen nicht vertretbar ist, besonders im Hinblick auf eine Untertherapierung durch temporären Entzug der Standardmedikation
    E.5 End points
    E.5.1Primary end point(s)
    End of the trial with final observation time point at day 566. This is independent of therapy success. However, the patient is free to terminate the participation any time.
    Endpunkt der Studie ist die finale Untersuchung an Tag 566. Dieser ist unabhängig vom Therapieerfolgen. Jedoch hat der Patient jederzeit die Möglichkeit seine Teilnahme zu beenden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    n/a
    n/a
    E.5.2Secondary end point(s)
    n/a
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    n/a
    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 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
    Investigation of underlying physiologic and especially immunologic mechanisms to explain the positive effects on patients pain perception and agility.
    Untersuchung zugrunde liegender physiologischer und ganz besonders immunologischer Wirkungsweisen um die positiven Effekte auf das Schmerzempfinden und die Beweglichkeit der Patienten zu erklären.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.2.4Number 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 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 (aprox. day 566 = last examination)
    Letzter Tag des letzten Teilnehmer (ca. Tag 566 = letzter Untersuchungszeitpunkt)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 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 state116
    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 Decision2017-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-10
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