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    Summary
    EudraCT Number:2015-000180-13
    Sponsor's Protocol Code Number:HAT1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000180-13
    A.3Full title of the trial
    The value of a High-Volume Image-Guided Injections (HVIGI) in chronic midportion Achilles tendinopathy: a double-blind, placebo-controlled, randomised clinical trial
    De waarde van Hoog-Volume Injecties (HVI) in chronische midportion Achilles tendinopathie: een dubbel-blinde, placebo-gecontroleerde, gerandomiseerde klinische studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HAT-study
    HAT-studie
    A.3.2Name or abbreviated title of the trial where available
    HAT-study
    HAT-studie
    A.4.1Sponsor's protocol code numberHAT1
    A.5.4Other Identifiers
    Name:Nederlands Trialregister (NTR)Number:TC = 4916
    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 SponsorMedisch Centrum Haaglanden
    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 supportSubsidieaanvraag loopt bij Reumafonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedisch Centrum Haaglanden
    B.5.2Functional name of contact pointAfdeling Sportgeneeskunde
    B.5.3 Address:
    B.5.3.1Street AddressBurgemeester Banninglaan 1
    B.5.3.2Town/ cityLeidschendam
    B.5.3.3Post code2262 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003170357 42 35
    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 Natrium Chloride
    D.2.1.1.2Name of the Marketing Authorisation holderBraun
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameNatrium Chloride
    D.3.2Product code 5/13593960/1110
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1
    D.3.9.3Other descriptive nameSTERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)
    D.3.9.4EV Substance CodeSUB79490
    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 typeIt is a normal NaCl saline solution. Normally it is used to fill up patiënts with hypovolemia.
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboParenteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic midportion Achilles tendinopathy
    Chronische midportion Achilles tendinopathie
    E.1.1.1Medical condition in easily understood language
    Chronic pain of the Achilles tendon
    Chronische pijn van de Achillespees
    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
    To investigate the value of High-Volume Image-Guided Injections in patiënts with chronic midportion Achilles tendinopathie.
    De effectiviteit onderzoeken van Hoog-Volume Injecties bij patiënten die lijden aan chronische midportion Achilles tendinopathie.
    E.2.2Secondary objectives of the trial
    To investigate the effect of the High-Volume Image-Guided Injections on the "neovascularisation" surrounding the Achilles tendon.
    Het effect van de Hoog-Volume Injecties onderzoeken op de mate van "neovascularisatie" om de Achillespees.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is a really small sub-study. We are interested in the effect of the High-Volume Image-Guided Injections (HVIGI's) on the "neovascularisation" on the short term. The first follow-up moment is 2 weeks after the injection. We want to know what the HVIGI's do in the first hour. To investigate this we will ask 20 patients (10 in the intervention- and 10 in the placebo group) to stay in the hospital for one our after the injection. After one our we will determine the amount of "neovascularisation" in these 20 patiënts.
    We willen een smalle zij-studie in ons onderzoek toepassen. Wij zijn erg geïnteresseerd in de werking van de Hoog-Volume Injecties (HVI's) op de korte termijn. Het eerste follow-up moment is 2 weken na de injectie. Wij zijn ook geïnteresseerd in het effect van deze HVI's op de "neovascularisatie" een uur na de injectie. Om dit te onderzoeken vragen we aan 20 patiënten (10 uit de interventie- en 10 uit de placebogroep) of ze een uurtje op de poli willen blijven na de injectie. Na dat uurtje zullen we de mate van "neovascularisatie" bepalen bij de 20 patiënten.
    E.3Principal inclusion criteria
    - Age 18-70 years.
    - Clinical diagnosis of chronic midportion Achilles tendinopathy: Painfull swelling of the Achilles tendon, 2-7 cm proximal to it’s calcaneal insertion.
    - Non-response to eccentric excercise program for 6 weeks.
    - Painfull Achilles tendon for more than 2 months.
    - Patiënten zijn tussen de 18-70 jaar.
    - De klinische diagnose chronische midportion Achilles tendinopathie (trias van pijn, zwelling en verminderde activiteit)
    - Patiënten hebben klachten voor twee maanden of langer.
    - Een excentrisch oefenprogramma van minimaal 6 weken heeft niet of onvoldoende resultaten gegeven.
    E.4Principal exclusion criteria
    - Clinical suspicion of insertional disorders.
    - Clinical suspicion of Achilles tendon rupture.
    - Clinical suspicion of plantar flexor tenosynovitis.
    - Clinical suspicion of peroneal tendinopathy or subluxation.
    - Clicical suspicion of sural nerve pathology.
    - Condition of the Achilles tendon caused by medication, such as quinolones and statins.
    - Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoïdosis.
    - Inability to perform a heavy load eccentric exercise program.
    - Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids).
    - Presence of pregancy.
    - Previous Achilles tendon rupture.
    - Patient has received surgical intervention for his injury.
    - A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication)
    - Inability to give informed consent.
    - Participation in other concomitant treatment programs.
    - Patient has already one side included in this study.
    - Patient does not wish, for whatever reason, to undergo one of the two treatments.
    - Klinische verdenking op insertie klachten van de Achillespees.
    - Klinische verdenking op een Achillespeesruptuur.
    - Klinische verdenking op plantair flexor tenosynovitis.
    - Klinische verdenking op peroneus tendinopathie of subluxatie.
    - Klinische verdenking op Nervus suralis pathologie.
    - De peesconditie is veroorzaakt door medicatie zoals chinolonen en statines.
    - De patient is bekend met een van de volgende aandoeningen: Spondylarthropathieën, jicht, hyperlipidemie, rheumatoïde artritis en sarcoïdose.
    - De patient is niet in staat om een zwaar excentrisch oefenprogramma uit te voeren.
    - De patient heeft recent (binnen 2 maanden) medicatie voorgeschreven gekregen die mogelijk een effect hebben op de symptomen en de peesgenezing. (Chinolonen antibiotica, corticosteroïden)
    - Aanwezigheid van zwangerschap.
    - Achillespeesruptuur in de voorgeschiedenis.
    - De patient heeft chirurgische interventie gehad voor zijn aandoening.
    - De patient is bekend met een medische conditie die de veiligheid van de injectie kan ondermijnen (Bijv. Een perifere vaatziekte, het gebruik van antistolling)
    - Onmogelijkheid om toestemming te geven voor het onderzoek.
    - Gelijktijdige deelname aan een ander behandelprogramma.
    - De patient is al met een been geïncludeerd in de studie.
    - Patient wenst niet, om welke reden dan ook, een van de beide behandelingen te ontvangen.
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome measurement is the VISA-A score. This measures pain, function and activity level. It is validated en reliable for the chronic Achilles tendinopathy.
    Onze primaire uitkomstmaat is de VISA-A score. Deze meet pijn, functie en activiteiten niveau en is een gevalideerde en betrouwbare vragenlijst die specifiek is voor deze aandoening.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T1 = 0 weeks
    T2 = 2 weeks
    T3 = 6 Weeks
    T4 = 12 weeks
    T5 = 24 weeks
    T1 = 0 weken
    T2 = 2 weken
    T3 = 6 weken
    T4 = 12 weken
    T5 = 24 weken
    E.5.2Secondary end point(s)
    - The painDETECT questionnaire.
    - Degree of neovascularisation (determined with standarised Power Doppler Ultrasonography examination)
    - Subjective patient satisfaction (excellent / good / fair / poor)
    - Return to sports (Return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports)
    - Time to return to full training in desired sport.
    - Compliance to the exercise programme.
    - De painDETECT vragenlijst
    - De mate van neovascularisatie (vastgesteld met de power doppler echografie)
    - De mate van tevredenheid over de behandeling (uitstekend, goed, redelijk, slecht)
    - De terugkeer in sport (terugkeer in gewenste sport op pre-blessure niveau, terugkeer in de gewenste sport maar op een lager niveau, terugkeer in sport maar niet in de gewenste sport, geen terugkeer in sport)
    - De tijd die nodig is om volledig terug te keren in de gewenste sport
    - De therapietrouw van de patient aan het oefenprogramma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T1 = 0 weeks
    T2 = 2 weeks
    T3 = 6 Weeks
    T4 = 12 weeks
    T5 = 24 weeks
    T1 = 0 weken
    T2 = 2 weken
    T3 = 6 weken
    T4 = 12 weken
    T5 = 24 weken
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 years2
    E.8.9.1In the Member State concerned months
    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: 80
    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 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 2015-03-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state80
    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)
    Patiënts with prolonging pain of the Achilles tendon can continue with the HVIGI's. This has to be determined in consultation with the Sports physician.
    Patiënten die last blijven houden van de Achillespees kunnen doorgaan met de HVIGI's. Of dit toegepast gaat worden wordt overlegd met de sportarts.
    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 Medisch Centrum Haaglanden
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-09
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