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    Summary
    EudraCT Number:2007-001196-10
    Sponsor's Protocol Code Number:RC27022007
    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:2007-07-23
    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 number2007-001196-10
    A.3Full title of the trial
    Etude d’évaluation de l’effet de Cuprum Metallicum 15 CH sur les crampes musculaires survenant en cours de dialyse chez des patients hémodialysés chroniques.

    Effect of Cuprum Metallicum 15 CH on muscle cramps at dialysis, evaluation study in chronic hemodialysed patients
    A.4.1Sponsor's protocol code numberRC27022007
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoire BOIRON
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CUPRUM METALLICUM
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire BOIRON
    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.3.1Product nameCUPRUM METALLICUM 15 CH
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Yes
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crampes musculaires chez le patients hémodialysés chroniques.

    Muscle cramps happening at dialysis in chronic hemodialysed patients.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059270
    E.1.2Term Hemodialysis-induced symptom
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028295
    E.1.2Term Muscle cramps
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de l'effet du Cuprum Metallicum 15 CH sur la durée de la première crampe survenue lors de la séance de dialyse.

    Evaluation of Cuprum Metallicum 15 CH effect on the duration of the first cramp occuring at dialysis session.
    E.2.2Secondary objectives of the trial
    Effet du Cuprum Metallicum 15 CH sur l'intensité de la crampe.
    Cuprum Metallicum 15 CH effect in cramp intensity.

    Statut de la réponse au traitement.
    Type of response to treatment after 3 and 6 minutes

    Tolérance du traitement à l'essai.
    Study treatment tolerance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Critères de sélection / Selection criteria :

    - Consentement éclairé écrit obtenu
    - written informed consent obtained

    - âgé de 18 à 85 ans
    - 18 to 85 years old

    - Patient hémodialysé chronique, soumis à 2 à 3 sénaces de dialyse par semaine depuis plus de 6 mois, présentant une pathologie rénale stabilisée.
    - Chronic hemodyalised patient, i.e. been undergoing 2 to 3 dialysis session a week
    for more than 6 months, presenting a stabilised renal pathology

    - At least one history of cramp at dialysis session in the month preceding the selection visit.
    - At least one history of cramp at dialysis session in the month precedind the selection visit.

    - Patient couvert par un régime de sécurité sociale.
    - patient under social security protection

    Inclusion criteria :

    - Patient présentant un épisode de crampe lors de la séance de dialyse. C'est l'apparition de cette crampe en cours de dialyse qui déterminera l'inclusion d'un patient sélectionné.
    - Patient presenting an episode of cramp at the dialysis session. It is the onset of that cramp during the dialysis session that will determine the inclusion of a selected patient.
    E.4Principal exclusion criteria
    Non selection criteria :

    - Patient insuffisant rénal présentant une patholgie rénale non stabilisée
    - Renal failure with non stabilised renal pathology

    - Patient dialysé depuis moins de 6 mois
    - Patient dialysed sinc less than 6 months

    - Patient présentant une pathologie associée susceptible de générer des douleurs ou des crampes musculaires pouvant interférer de l'avis de l'investigateur avec les critères de jugement de l'étude
    - With pains or muscle cramps generating pathology or any pathology considered by the investigator to interfere with evaluation criteria of the study.

    - Patient présentant une pathologie psychiatrique sévère,
    - Patient with a severe psychiatric pathology

    - Patiente enceinte ou allaitante
    - Pregnancy or breast feeding

    - Patient en période d'exclusion d'une précedente étude ou participant à un autre essai clinique
    - patient under exclusion period of o precedent study or participating in another clinical trial


    Non inclusion criteria :

    - Patient ayant pris un traitement visant à réduire la survenue des crampes musculaires 24 heures avantla visite d'inclusion.
    - patient having taken a muscle cramp onset reducing treatment 24 hours before the inclusion visit.
    E.5 End points
    E.5.1Primary end point(s)
    Sera considérée comme critère principal, la durée de la crampe musculaire ayant motivée la première prise du traitement alloué. Une comparaison des moyennes de cette durée sera effectuée entre groupe verum et groupe placebo. Les tests statistiques seront réalisés au seuil de 0,05.

    Cramp duration following study treatment intake.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned6
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2007-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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