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    Summary
    EudraCT Number:2015-003587-36
    Sponsor's Protocol Code Number:684/MODREC/15
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-02-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003587-36
    A.3Full title of the trial
    Chronic Tendinopathy: The Biomechanical Associations and EfFicacy of Injectable Therapy (BE FIT) Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chronic Tendinopathy: The Biomechanical Associations and EfFicacy of Injectable Therapy (BE FIT) Study
    A.3.2Name or abbreviated title of the trial where available
    Biomechanical Associations & EfFicacy of IInjectable Therapy (BE FIT)
    A.4.1Sponsor's protocol code number684/MODREC/15
    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 SponsorDirectorate of Defence Rehabilitation
    B.1.3.4CountryUnited Kingdom
    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 supportLoughborough University
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDefence Medical Rehabilitation Centre Headley Court
    B.5.2Functional name of contact pointBarker-Davies
    B.5.3 Address:
    B.5.3.1Street AddressDMRC Headley Court
    B.5.3.2Town/ cityAcademic Dept of Military Rehabilitation
    B.5.3.3Post codeKT186JW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01372371310
    B.5.6E-mailrobbarker-davies@doctors.net.uk
    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 Marcain Polyamp Steripack 0.5%
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMarcain Polyamp Steripack 0.5%
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine Hydrocholride
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5%
    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.IMP: 2
    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 Sodium Chloride 0.9%
    D.2.1.1.2Name of the Marketing Authorisation holderHameln Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSodium Chloride 0.9%
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Chloride 0.9%
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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.IMP: 3
    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 Efcortesol
    D.2.1.1.2Name of the Marketing Authorisation holderAmdipharm UK Limited Capital House, 85 King William Street, London EC4N 7BL, UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEfcortesol 100mg/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydrocortisone
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100ml/1ml
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboInfiltration
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic degenerative Achilles and patella tendinopathy patients, with neovascularisation on USS, who have failed best practice rehabilitation including Eccentric Loading (EL), Heavy Slow Resistance Training (HSR) and Extra-Corporal Shock Wave Therapy (ESWT) will be randomised to one of three injections: 3ml of Marcain Polyamp 0.5% (Placebo) or 10 ml of Marcain Polyamp 0.5%+2.5ml Sodium Chloride 0.9% or 10ml of Marcain Polyamp 0.5%+2.25ml Sodium Chloride 0.9% + 0.25ml Efcortesol 100mg/ml.
    E.1.1.1Medical condition in easily understood language
    Patients with long term Achilles and knee tendonopathy (tendinitis) who have failed to improve with best practice physiotherapy and shockwave therapy and have new blood vessels growing into the damage
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000433
    E.1.2Term Achilles tendinitis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10034123
    E.1.2Term Patellar tendinitis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Hypothesis 1

    High Volume Effect in both the presence and absence of steroid is superior to placebo.

    Implications

    The literature contains many papers by the same group indicating that the proposed successes may be operator dependent. If we can demonstrate the High Volume Effect to work independently with a simpler technique then Defence Rehabilitation will benefit in a way that is not currently applicable from the literature. Frequently innovative sports medicine procedures have become commonplace without sufficient evidence and at high risk of bias53. The lack of control groups in trials relating to the High Volume Effect desperately needs to be addressed.

    E.2.2Secondary objectives of the trial
    Hypothesis 2

    HVE without CS is non-inferior to HVE with CS.

    Implications

    Separating the effect of HVE and CS, two very different mechanisms of action, is vital to further injectable therapy in tendinopathy. By conducting this trial Defence Rehabilitation will provide further evidence for its own pathway and will also be making a significant contribution to the scientific literature.

    Hypothesis 3

    Specific biomechanical factors will be associated with patella tendinopathy in symptomatic patients during walking and one leg squat assessments.

    Implications

    The number of participants will also be comparable to previous trials allowing us to build on those findings. Use of our patients in this trial will allow us to confirm if these associations are relevant to the defence population as much of the current data is extrapolated from very specifically trained athletes. Confirmed strategies can then be emphasised throughout Defence. Education of personnel at an early stag
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Chronic Achilles and patella tendinopathy patients
    Age 18-55
    Male
    No or minimal improvement with physical rehabilitation pathway outlined below
    Minimum duration of symptoms of 6 months
    US evidence of neovascularization
    Patients must be medically downgraded and not deployable
    E.4Principal exclusion criteria
    Concurrent alternate lower limb diagnosis
    Female
    Anticoagulant medication
    Previous tendon surgery or injection
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcomes will be:

    a. The Visual Analogue Scale (VAS) for pain. This is a subjective score from the participant on pain level recorded by asking the patient to mark along a 100mm line their pain level with 0mm representing no pain and 100mm maximal pain.

    b. Validated Victoria Institute of Sport-Achilles (VISA-A)55 and Victoria Institute of Sport-Patella (VISA-P)1 scores for pain and function. These are validated questionnaires that are widely accepted throughout the literature. They are recommended for use in research to enable direct comparison and use in meta-analyses. The questionnaires are self-explanatory and can be completed by the participant alone.

    An administrator not involved with the trial will check questionnaires for basic errors eg missing out part of the form. The questionnaires will be completed in a separate area of the waiting room away from treating clinicians and other participants.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 6 weeks, 3months and 6 months
    E.5.2Secondary end point(s)
    Secondary outcomes will be:

    a. The degree of neovascularisation measured using the modified Ohberg Score2. This will be recoded as follows:

    0= No vessels visible
    1= 1 vessel mostly anterior to the tendon
    2= 1 or 2 vessels throughout the tendon
    3= 3 vessels throughout the tendon
    4= More than three vessels throughout the tendon

    Images will be stored to disk and kept in a locked cabinet within the DMRC Academic Department of Military Rehabilitation.

    Scoring will be made by one of the two operators delivering injections either Col A Nicol or Dr I McCurdie who will be blinded to type of injectate as described above.

    b. The Functional Activity Assessment (FAA) score which is validated in the military population3. The score being:

    FAA 1= Fully Fit
    FAA 2= Fit for trade and fit for restricted general or military duties
    FAA 3= Unfit for trade but fit for restricted general or military duties
    FAA 4= Unfit for all but sedentary duties
    FAA 5= Off all duties

    This is self-reported by the participant.

    There will biomechanical evaluation (using kinetics and kinematics) of a patella tendinopathy subgroup nested within the trial at baseline and 6 months follow up only.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 6 weeks, 3months and 6 months.

    There will be biomechanical evaluation (using kinetics and kinematics) of a patella tendinopathy subgroup nested within the trial at baseline and 6 months follow up only. This will be compared with a group of healthy controls.

    There will be a correlational study multiple regression analysis of epidemiological factors that will be used to look for predictors between tendinopathy participants and matched controls.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months7
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    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)
    Should the hypothesis that the High Volume Effect is superior to local anaesthetic placebo prove correct any participant who had placebo injection will have a High Volume Effect injection made available to them on their completion of the trial (i.e. after 6 months).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-13
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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