Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001068-27
    Sponsor's Protocol Code Number:W2020.014
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001068-27
    A.3Full title of the trial
    PAmidronate for Pain in Sternocostoclavicular Hyperostosis: the PAPS-study, a double-blind randomized placebo-controlled trial
    PAmidronate voor Pijn in Sternocostoclaviculaire hyperostose: de PAPS-studie, een dubbel-blind gerandomiseerde placebo gecontroleerde studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pamidronate for Pain in Sternocostoclavicular Hyperostosis: the PAPS-study
    PAmidronate voor Pijn in Sternocostoclaviculaire hyperostose: de PAPS-studie
    A.3.2Name or abbreviated title of the trial where available
    PAPS-trial
    PAPS-studie
    A.4.1Sponsor's protocol code numberW2020.014
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportReumaNederland
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointLUMC department of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715268174
    B.5.6E-mailbot@lumc.nl
    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 Pamipro 3 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    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 namePamidronate
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 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 placeboInfusion
    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
    Sternocostoclavicular Hyperostosis
    Sternocostoclaviculaire Hyperosteose
    E.1.1.1Medical condition in easily understood language
    Sternocostoclavicular Hyperostosis is a chronic bone disorder of the anterior chest region, in which inflammation within the bone leads to pain and compromised shoulder function.
    Sternocostoclaviculaire hyperosteose is een chronische botaandoening van de borstkas, waarbij een ontsteking in het bot pijn en verminderde schouderfunctie veroorzaakt.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective to demonstrate that in SCCH patients with pain 3-monthly treatment with pamidronate will result in a significant decrease inmaximum pain score (measured by BPI) as compared to placebo.
    Het primaire doel van het onderzoek is aan te tonen dat in SCCH patienten met pijn 3-maandelijkse behandeling met pamidronaat een significante verlaging in maximum pijnscore, gemeten met BPI, teweegbrengt in vergelijking met placebo.
    E.2.2Secondary objectives of the trial
    • To study the number of patients with mild pain (maximal pain 4 or lower) after 3-monthly treatment with pamidronate
    • To study the number of patients with 50% reduction in maximal pain (VAS score in BPI)
    • To study change in shoulder rating questionnaire (SRQ) and facets of Shoulder function assessment (SFA) score and range of motion
    • To study improvement in general health as measured with Short Form Health Survey (Sf-36), work activity score, and physical activity International Physical Activity Questionnaire (IPAQ, short form, previous 7 days)
    • To investigate partner burden
    • To study a change in standard dose of analgesics
    • Evaluation of confounding factors for outcome of treatment
    • Significant alteration of inflammation and quantifiable decrease in Na18F-PET/CT tracer uptake of SCCH lesions
    • Evaluation of a possible neuropathic component of the reported pain (pain detect)
    • To evaluate cost-effectiveness of therapy in an economic evaluation
    • Onderzoeken hoeveel patienten resteren met milde pijn (maximale pijn op BPI van 4 of lager) na 3 maandelijkse behandeling met pamidronaat
    • Onderzoeken hoeveel patienten 50% reductie van maximale pijn op BPI bereiken
    • De verandering in shoulder rating questionnaire (SRQ) en facetten van de Shoulder function assessment (SFA) bestuderen, en range of motion
    • De verbetering in algemene gezondheid bestuderen, gemeten met Short Form Health Survey, work activity score, and physical activity International Physical Activity Questionnaire
    • Belasting voor de mantelzorger te evalueren
    • De verandering in dosering van analgetica
    • Evalueren van confounders voor de uitkomstmaten
    • Het bestuderen van significante veranderingen wat betreft inflammatie en kwantificeerbare vermindering van tracer uptake op Na18F-PET/CT in SCCH lesies
    • Evaluatie van een mogelijke neuropathische component van de pijn
    • De kosten-effectiviteit analyseren met behulp van een economische analyse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (> 18 years of age) with an established diagnosis of SCCH based on clinical and radiologic features and increased radioactive tracer uptake on 99mTc scan with a reported maximum pain score of 6/10 or higher, and no treatment with bisphosphonates for the previous 6 months, and willing to participate.
    Volwassen patienten (18 jaar of ouder) met de diagnose SCCH op basis van de klinische en radiologische kenmerken en verhoogde tracer uptake op 99mTc scan, met een maximale pijnscore 6 of meer uit 10, en niet behandeld met bisfosfonaten in de voorafgaande 6 maanden.
    E.4Principal exclusion criteria
    Patients who are under 18 years of age will be excluded. Active pregnancy wish, pregnancy or nursing are exclusion criteria. Patients with generalized pain without SCCH related pain are excluded. Bisphosphonate use during previous 6 months before study entry, bisphosphonate allergy, estimated glomerular filtration rate < 30 ml/min, uncontrolled endocrine abnormalities, and active cancer treatment are exclusion criteria. Patients will not be included in the study in case of language barrier, severe co-morbidity, including poor mobility and other causes preventing attendance for control visits, as are mentally disabled patients. In case of poor dental hygiene or inadequate dental care, patients will only be enrolled after oral maxillary surgeon consultation.
    Patienten onder de 18 jaar worden geexcludeerd. Actieve zwangerschapswens, zwangerschap of borstvoeding zijn exclusiecriteria. Patiënten met gegeneraliseerde pijn zonder SCCH gerelateerde pijnklachten worden geexcludeerd. Andere exclusiecriteria: gebruik van bisfosfonaten in de 6 maanden voorafgaande aan start van de studie, allergie voor bisfosfonaten, geschatte klaring < 30 ml/min, niet-gecontroleerde endocriene ziekten, actieve kankerbehandeling, ernstige taalbarriere, ernstige co-morbiditeit inclusief slechte mobiliteit of mentale retardatie. In geval van slechte mondhygiëne inclusie is alleen toegestaan na akkoord van een kaakchirurg.
    E.5 End points
    E.5.1Primary end point(s)
    Change in score of maximal pain on BPI (VAS 0-10) from baseline to 6 months.
    Verandering in score van maximale pijn op BPI van baseline in vergelijking met 6 maanden
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and at 6 months
    baseline en bij 6 maanden
    E.5.2Secondary end point(s)
    • Change in range of motion
    • Number of patients with mild pain (maximal pain as measured with VAS score in BPI 4 or lower)
    • Number of patients with 50% reduction in maximal pain (VAS score in BPI)
    • Change in shoulder rating questionnaire and facets of SFA score (among which are ability to dress)
    • Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden
    • Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment.
    • Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion
    • Evaluation of a possible neuropathic component of the reported pain
    • Change in biochemical markers of inflammation
    • Amount of tracer uptake of SCCH lesions on Na18F-PET/CT
    • Spinal involvement
    • Cost-effectiveness
    Verandering in range of motion
    Aantal patienten met milde pijn (maximale pijn gemeten met VAS score bij BPI 4 of lager)
    Aantal patienten met 50% reductie van maximale pijn gemeten met VAS bij BPI
    Verandering in schouderklachten
    Verandering in algemene gezondheid, kwaliteit van leven, moeheid, werk, fysieke activiteit, belasting voor eventuele mantelzorgers
    Verandering in standaarddosering van analgetica inclusief NSAIDs als bewijslast voor effectiviteit therapy
    Evaluatie van mogelijke confounders zoals delay in diagnose en mate van tracer uptake, pijn en range of motion op baseline
    Evaluatie van mogelijke neuropathische component van de pijn
    Mate van tracer uptake op NaF PET scan
    Verandering in biochemische markers en inflammatieparameters
    Kosten effectiviteit
    Spinale betrokkenheid
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and at 6 months
    Baseline en bij 6 maanden
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Monitor disease activity
    Monitoren van ziekteactiviteit
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    After 6 months, the trial continues on an open label basis for pamidronate, which enables crossover
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state90
    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)
    Post trial treatment is in line with normal treatment for SCCH patients at our center: 3-monthly 30 mg pamidronate infusions.
    Na de trial zullen patienten met pijnklachten of ziekteactiviteit op dezelfde wijze als bij de standaard SCCH-zorg behandeld worden, met 3-maandelijkse 30 mg pamidronaat infusen.
    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 Netherlands Rheumatoid Arthritis Surgical Society (NERASS)
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Dutch Arthritis Society
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation NVE BoNE
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation SpA Working Group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 18:05:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA