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   44335   clinical trials with a EudraCT protocol, of which   7366   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:2015-000145-24
    Sponsor's Protocol Code Number:PI2015_843_0001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 number2015-000145-24
    A.3Full title of the trial
    Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery (CRPS-VITC)
    Rôle préventif de la vitamine C sur l’apparition à 6 mois du SDRC (syndrome douloureux régional complexe) de type 1 dans la chirurgie programmée du membre supérieur : essai multicentrique contrôlé randomisé en double insu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery (CRPS-VITC)
    Rôle préventif de la vitamine C sur l’apparition à 6 mois du SDRC (syndrome douloureux régional complexe) dans la chirurgie programmée du membre supérieur
    A.3.2Name or abbreviated title of the trial where available
    SDRC VitC
    A.4.1Sponsor's protocol code numberPI2015_843_0001
    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 SponsorCHU Amiens - Picardie
    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 supportFrench Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens Picardie
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address1 place Victor Pauchet
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80000
    B.5.3.4CountryFrance
    B.5.4Telephone number33322668060
    B.5.5Fax number33322667911
    B.5.6E-mailfin.loic@chu-amiens.fr
    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 No
    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 nameAcide ascorbique
    D.3.2Product code Vitamine C
    D.3.4Pharmaceutical form Capsule
    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 INNC-Vitamin
    D.3.9.3Other descriptive nameL-ASCORBIC ACID
    D.3.9.4EV Substance CodeSUB127188
    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 placeboCapsule
    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
    Algoneurodystrophy
    CRPS type 1
    Algoneurodystrophie
    SDRC type 1
    E.1.1.1Medical condition in easily understood language
    CRPS type 1
    SDRC type 1
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10001665
    E.1.2Term Algoneurodystrophy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery.
    L’objectif principal de cette étude est de montrer la supériorité de la vitamine C par rapport au placebo dans la prévention de la survenue à 6 mois d’un SDRC de type 1 lors d’une chirurgie programmée du membre supérieur.
    E.2.2Secondary objectives of the trial

    - to compare between the 2 arms the occurrence of CRPS Type 1, one year after surgery
    - Descriptive analysis (overall and per arm) of the population affected by CRPS Type 1: age, sex, history, type of surgery.
    - Evaluation of tolerance and attendance taking vitamin C in pre and post operative period.
    L’objectif secondaire est de comparer entre les 2 bras :
    • La survenue à 1 an d’un SDRC de type 1.

    D’autres objectifs secondaires portent sur :
    • Analyse descriptive (globale et par bras) de la population touchée par le SDRC de type 1 : âge, sexe, antécédents, type d’intervention chirurgicale.
    • Evaluation de la tolérance et de l’assiduité à la prise de vitamine C en période pré et post opératoire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients over 18 yo
    - patients undergoing major surgery of the upper limb
    - patients able to give their consent to follow the protocol of treatment and monitoring.
    • Patient majeur programmé pour une chirurgie du membre supérieur,
    • Patient ayant signé un consentement éclairé,
    • Patient bénéficiant d’une couverture sociale
    E.4Principal exclusion criteria
    - children,
    - patients under guardianship,
    - pregnant or lactating women,
    - patients with hemochromatosis,
    - allergy or known hypersensitivity to one of the molecules of treatment,
    - patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2,
    - patients unable due to personal or professional mobility, to conduct post-operative follow up,
    - patients undergoing surgery with nerve suture with nerve graft, emergency surgery,
    - patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
    - patients with chronic kidney disease
    • Patient ne souhaitant pas faire partie de l’étude, ou hors d’état d’exprimer son consentement,
    • Patient sous tutelle ou curatelle ou privé de liberté,
    • Femme en âge de procréer sans méthode contraceptive efficace,
    • Patiente enceinte ou en cours d’allaitement,
    • Patient aux antécédents d’hémochromatose ou porteur d’hémochromatose,
    • Patient souffrant d’une insuffisance rénale chronique,
    • Patient souffrant d’un déficit en G6PD,
    • Patient souffrant d’une allergie ou d’une hypersensibilité à l’une des molécules du traitement,
    • Patient souffrant ou ayant souffert d’un SDRC de type 1 ou de type 2
    • Patient souhaitant un suivi hors centres référents,
    • Patient incapable du fait d’une mobilité personnelle, professionnelle d’effectuer le suivi post opératoire,
    • Patient bénéficiant d’une chirurgie avec suture nerveuse, avec greffe nerveuse,
    • Patient nécessitant deux actes chirurgicaux sur le même membre,
    • Patient pris en charge en urgence,
    E.5 End points
    E.5.1Primary end point(s)
    Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
    Le critère de jugement principal est la présence ou non d’un SDRC de type 1 à 6 mois.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after surgery
    6 mois après l'opération chirurgicale
    E.5.2Secondary end point(s)
    - Epidemiological description of CRPS affected population
    - Appearance of a complex regional pain syndrome (CRPS) 12 months after surgery
    - C Vitamin tolerance and protocol compliance
    • Analyse descriptive de la population touchée par le SDRC de type 1 : âge, sexe, antécédents. Cette évaluation se basera sur les données des patients inclus.
    • Apparition d’un SDRC de type 1 à un an, selon les mêmes critères de diagnostic positif décrits au chapitre précédent.
    • Évaluation de la tolérance et de l’assiduité à la prise de vitamine C par le recueil des données de tolérance à l’interrogatoire le jour de l’intervention et aux consultations post-opératoires (6 et 12 mois).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months after surgery
    6 mois et 12 mois après l'opération chirurgicale
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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
    last patient last visit
    Dernière visite du dernier patient inclus
    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 months30
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state1000
    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)
    normal treatment of that condition
    Prise en charge normale
    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 Decision2015-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    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-Fri May 09 22:09:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA