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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2014-005612-41
    Sponsor's Protocol Code Number:15-15
    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:2015-11-17
    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 number2014-005612-41
    A.3Full title of the trial
    Vitamin c to Improve Tissue healing by Administration of Multiple INtravenous dosages
    Het effect van intraveneuze suppletie van ascorbinezuur op wondgenezing bij vaatchirurgische patiënten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin c to improve wound healing after vascular surgery
    Vitamine c ter bevordering van wondgenezing na vaatchirurgie
    A.3.2Name or abbreviated title of the trial where available
    VITAMIN
    VITAMIN
    A.4.1Sponsor's protocol code number15-15
    A.5.4Other Identifiers
    Name:The Netherlands National Trial Register Number:NTR5397
    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 SponsorMeander Medical Centre
    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 supportMeander Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMeander Medical Centre
    B.5.2Functional name of contact pointJ.L.W. Pot
    B.5.3 Address:
    B.5.3.1Street AddressMaatweg 3
    B.5.3.2Town/ cityAmersfoort
    B.5.3.3Post code3813 TZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310338505050
    B.5.5Fax number00310338502306
    B.5.6E-mailjlw.pot@meandermc.nl
    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 Ascorbinezuur CF 100 mg/ml, injectievloeistof
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASCORBIC ACID
    D.3.9.1CAS number 50-81-7
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 infusion
    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
    Patients with planned revascularisation surgery on the lower extremities.
    Patiënten met een geplande revascularisatie aan de onderste extremiteiten.
    E.1.1.1Medical condition in easily understood language
    Patients with surgery on the bloodvessels in legs.
    Patiënten met operatie aan de bloedvaten in benen.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10003451
    E.1.2Term Ascorbic acid
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10063919
    E.1.2Term Bypass surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10036892
    E.1.2Term Promotion of wound healing
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10061407
    E.1.2Term Vascular bypass graft
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10053375
    E.1.2Term Peripheral revascularization
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the effect of intravenously administered dosages of ascorbic acid on wound healing in patients with open revascularisation of the lower extremities.
    Evaluatie van het effect van intraveneus toegediende doseringen van ascorbinezuur op wondgenezing bij vaatchirurgische patiënten met open revascularisatie van de onderste extremiteiten.
    E.2.2Secondary objectives of the trial
    Evaluation of the effect of intravenously administered dosages of ascorbic acid on secondary wound healing (pre-surgical existing ulcers) post-surgical complications, mortality and duration of hospital stay.
    Evaluatie van het effect van intraveneus toegediende doseringen van ascorbinezuur op secundaire wond genezing (pre-operatief bestaande ulcera), post-OK complicaties, mortaliteit en opnameduur.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Planned open arterial revascularisation surgery on 1 or 2 legs.
    Age > 18 yrs.
    Vascular disease fontaine IIb or higher.
    Geplande open arteriële revascularisatie chirurgie aan 1 of 2 benen.
    Leeftijd > 18 jaar.
    Vaatlijden fontaine IIb of hoger.
    E.4Principal exclusion criteria
    Age < 18yrs.
    Hyperoxaluria.
    Patients on dialysis.
    Paroxismal nocturnal haemoglobinuria.
    G6P deficiency.
    Recurrent kidney stones.
    Hemochromatosis.
    Hemosiderosis.
    Usage of deferoxamine (in the past).
    Immunological disease.
    Pregancy.
    Bilateral surgery, other than the revascularisation.
    Intolerance for study medication.
    Mentally incompetent patients.
    Previous participation in this study.
    Leeftijd < 18jr.
    Hyperoxalurie.
    Dialysepatiënten.
    Patiënten met paroxismale nachtelijke hemoglobinurie.
    G6PD deficiëntie.
    Recidiverende nierstenen.
    Hemochromatose.
    Hemosiderose.
    Gebruik van deferoxamine (in het verleden).
    Immunologische aandoening.
    Zwangeren.
    Bilaterale operatie, anders dan de perifere bypass.
    Intolerantie voor studie medicatie.
    Niet wilsbekwame patiënten.
    Eerdere deelname aan dit onderzoek.
    E.5 End points
    E.5.1Primary end point(s)
    Improved reduction in wound area of the vascular surgical wound of at least 30%. (corrected for ascorbineacid bloodlevel)
    Versnelde afname van wondoppervlak van de vasculaire operatiewond van tenminste 30%. (gecorrigeerd voor ascorbinezuur bloedspiegel)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks post-surgery.
    4 weken post-operatief.
    E.5.2Secondary end point(s)
    Relation between the ascorbicacid bloodlevel and the reduction in wound surface area of the primary surgical wound 4 weeks post-surgery.
    Reduction in wound surface area of a secondary wound (pre-surgical existing) 4 weeks post-surgery (corrected for baseline ascorbicacid level)
    Decreasing the incidence of woundinfections of the surgical wound within 30 days post-surgery(corrected for baseline ascorbicacid level)
    Reduction of hospital stay (corrected for baseline ascorbicacid level)
    Reduction of the number of readmissions within 30 days post-surgery(corrected for baseline ascorbicacid level)
    Reduction of the number of 'all cause complications' within 30 days post-surgery (corrected for baseline ascorbicacid level)
    Reduction of mortality within 30 days post-surgery (corrected for baseline ascorbicacid level)
    Reduction of the time till median wound surface area healing in case the wounds in both groups are fully closed within 30 days post-surgery. (corrected for baseline ascorbicacid level)
    Relatie tussen de ascorbinezuurspiegel en de reductie in wondoppervlak (%) van de primaire operatiewond, 4 weken postoperatief.
    Reductie in wondoppervlak (%) van een eventueel preoperatief aanwezig ulcus aan de onderste extremiteiten, 4 weken postoperatief door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verlagen van de incidentie van wondinfecties van de primaire operatiewond binnen 30 dagen postoperatief door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verkorten van de opnameduur door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verlagen van het aantal vaatchirurgische heropnames binnen 30 dagen postoperatief door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verlagen van het aantal ‘all cause complications’ binnen 30 dagen postoperatief door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verlagen van de mortaliteit binnen 30 dagen postoperatief door intraveneuze suppletie van ascorbinezuur bij vaatchirurgie, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    Het verlagen van de tijd tot mediane wondgenezing indien in beide groepen de wonden volledig gesloten zijn op t = 4 weken, waarbij gecorrigeerd wordt voor de baseline ascorbinezuurspiegel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks post-surgery.
    4 weken post-operatief.
    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 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
    To identify the relation of the bloodlevel of ascorbic acid to woundhealing.
    De identificatie van de relatie tussen de bloedspiegel van ascorbinezuur en wondgenezing
    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 years1
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 state40
    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
    Geen
    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 Decision2015-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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