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:2013-002057-29
    Sponsor's Protocol Code Number:2013-802
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-002057-29
    A.3Full title of the trial
    DOuleurs chroniques et VItamine D : une étude pilote en médecine de ville.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DOuleurs chroniques et VItamine D : une étude pilote en médecine de ville
    A.3.2Name or abbreviated title of the trial where available
    DOVID
    A.4.1Sponsor's protocol code number2013-802
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    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 supportAPICIL
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointValérie PLATTNER
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON
    B.5.3.4CountryFrance
    B.5.4Telephone number04 72 11 52 13
    B.5.5Fax number04 72 11 51 90
    B.5.6E-mailvalerie.plattner@chu-lyon.fr
    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 UVEDOSE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES CRINEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHOLECALCIFEROL
    D.3.9.3Other descriptive nameCHOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB34314
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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 placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Douleurs chroniques
    E.1.1.1Medical condition in easily understood language
    Douleurs chroniques
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10049475
    E.1.2Term Chronic pain
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimer, à 3 mois, l’efficacité d’une supplémentation en vitamine D versus placebo sur la diminution de l’intensité des douleurs musculo-squelettiques non-systématisées chez des patients de 18 à 50 ans présentant un déficit en vitamine D.
    E.2.2Secondary objectives of the trial
    Estimer l’efficacité d’une supplémentation en vitamine D versus placebo, à 3 mois, sur :
    1/ l’évolution de l’intensité maximale et de l’intensité minimale des douleurs.
    2/ la diminution de l’impact des douleurs sur les activités quotidiennes
    3/ la diminution de la consommation de médicaments à visée antalgique
    4/ la diminution de la consommation de soins (consultations et arrêts de travail)
    5/ l’amélioration sur la qualité de vie mesurée par le questionnaire SF-36
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hommes et femmes âgés de 18 à 50 ans
    - Présentant des douleurs diffuses chroniques :Douleurs musculo-squelettiques non systématisées, pour lesquelles un bilan étiologique a été mené antérieurement et s’est révélé négatif
    - Evoluant depuis au moins deux mois
    - Objectivées par un questionnaire type
    - Avec ou sans prise de traitements à visée antalgique
    - Présentant un déficit en vitamine D objectivé par un taux de 25(OH)vitamine D <20.8 ng/L ou 52 nmol/L lors de la visite d’inclusion
    E.4Principal exclusion criteria
    - Patient ostéoporotique ou présentant une ostéopénie connue non traité.
    - Origine identifiable des douleurs :
    o Pathologies néoplasiques ou paranéoplasiques,
    o Douleurs post traumatiques,
    o Rhumatisme inflammatoire chronique (Polyarthrite rhumatoïde, Rhumatisme psoriasique et autre Spondylarthropathie),
    o Arthrose,
    o Syndrome Algodystrophique,
    o Fibromyalgie
    - Patients présentant une pathologie intercurrente connue en cours à l’inclusion pouvant interférer avec le métabolisme de la vitamine D :
    o Insuffisance hépatique ou rénale
    o Malabsorption dont maladie coeliaque, maladie de Whipple, dérivation intestinale, syndrome de l’intestin court et maladie inflammatoire de l’intestin
    o Hypo/hyper thyroidie ou hypo/hyper parathyroidie non contrôlée
    o Cancer et lymphomes connus
    o Maladies granulomateuses (sarcoidose, silicose)
    - Hypercalcémie actuelle ou passée
    - Traitement par vitamine D au long cours ou au moins une prise dans les 6 mois précédents l’inclusion
    - Situation s’accompagnant d’une vulnérabilité accrue à l’hypercalcémie (par exemple : arythmie ou maladie cardiaque connue, traitement par digitalique et sujets souffrant de lithiase rénale)
    - Grossesse (test urinaire) ou allaitement en cours
    - Pathologie psychiatrique entravant gravement la compréhension
    - Difficulté de compréhension du français oral
    - Intolérance au produit testé ou à un des excipients
    - Non bénéficiaire d’un régime de sécurité sociale
    - Incapacité légale ou capacité légale limitée
    - Refus du patient
    E.5 End points
    E.5.1Primary end point(s)
    Intensité de la douleur en général, à 3 mois, mesurée par l’item 5 de l’échelle BPI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 mois après l'inclusion
    E.5.2Secondary end point(s)
    o Autres items d’évaluation de la douleur de l’échelle BPI (intensité maximale - item 3, intensité minimale - item 4, intensité au moment du remplissage – item 6), mesurés à J1, J45 et J90
    o Impact des douleurs sur les activités quotidiennes (gêne occasionnée par les douleurs – item 9 du BPI), mesurés à J1, J45 et J90
    o Consommation de médicaments antalgiques (Quantité, fréquence et durée), ces données seront recueillies lors des entretiens téléphoniques à J1, J45 et J90 par un questionnaire standardisé, les noms, classes et posologies des traitements seront recensés. Les patients recevront un carnet afin de recenser les modifications de leur traitement antalgique entre les appels.
    o Consommation de soins (consultations médicales et paramédicales, arrêts de travail), ces données seront recueillies lors des entretiens téléphoniques à J1, J45 et J90 par un questionnaire standardisé, le nombre de consultations, le type de professionnel (paramédical ou médical, médecin généraliste ou spécialiste, spécialité), le motif de consultation, le nombre de jours d’arrêts de travail et le motif seront recensés. Les patients recevront un carnet afin de noter ces données entre les appels.
    o Qualité de vie, mesurée à l’aide du questionnaire de qualité de vie validé Short Form 36 (SF36), à J1 et J90.
    E.5.2.1Timepoint(s) of evaluation of this end point
    J1, J45 et J90
    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 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) Yes
    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 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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    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 years
    E.8.9.1In the Member State concerned months7
    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: 100
    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 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 state100
    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
    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 Decision2013-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    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 22:33:45 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA