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    Summary
    EudraCT Number:2012-003417-34
    Sponsor's Protocol Code Number:D-CURE-IV-12-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-26
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003417-34
    A.3Full title of the trial
    A phase IV, two-armed, randomised, cross-over study to compare the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months.
    Etude de phase IV ,à deux bras, randomisée et croisée afin de comparer la « compliance » d’une administration une fois par mois de vitamine D3 (D-CURE®) à l’administration quotidienne d’une dose fixe d’une combinaison de vitamine D3 et de calcium (STEOVIT FORTE®) pendant deux périodes de 6 mois.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Compliance study to evaluate which vitamin D treatment is the easiest to take for the patient.
    Etude de compliance afin d'identifier quel traitement de vitamine D est le plus facile d'usage pour le patient.
    A.3.2Name or abbreviated title of the trial where available
    MODACO
    A.4.1Sponsor's protocol code numberD-CURE-IV-12-1
    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 SponsorLABORATOIRES SMB S.A.
    B.1.3.4CountryBelgium
    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 supportLABORATOIRES SMB S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATOIRES SMB S.A.
    B.5.2Functional name of contact pointCLINICAL DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street Address26-28 RUE DE LA PASTORALE
    B.5.3.2Town/ cityBRUSSELS
    B.5.3.3Post code1080
    B.5.3.4CountryBelgium
    B.5.4Telephone number32 2 412 09 93
    B.5.5Fax number32 2 412 09 91
    B.5.6E-mailclinique@smb.be
    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 D-CURE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES SMB S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 solution
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeD-CURE-IV-12-1
    D.3.9.3Other descriptive nameCOLECALCIFEROL CONCENTRATE (WATER DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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 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 STEOVIT FORTE ®
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED BELGIUM
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Chewable tablet
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameCOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB11818MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium carbonate
    D.3.9.1CAS number 471-34-1
    D.3.9.3Other descriptive nameCALCIUM CARBONATE
    D.3.9.4EV Substance CodeSUB13166MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients are over 50 years old and do not present any significant medical conditions
    E.1.1.1Medical condition in easily understood language
    Patients are over 50 years old and do not present any significant medical conditions
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10047626
    E.1.2Term Vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 present study is to assess the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months and to see their effect on the level of vitamin D.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Volunteers must satisfy the following criteria before entering the study:
    1)Male and female over 50 years old (50 years inclusive);
    2)Presenting a Body Mass Index (BMI) between 18 and 35 kg/m² inclusive;
    3)Able to comply with all study procedures;
    4)Provide written, informed consent to participate in the study, indicated by a personal signature and date on the volunteer consent form;
    E.4Principal exclusion criteria
    Volunteers who meet any of the following criteria will be excluded from participating in the study:

    1)Volunteers with any sensitivity or allergy to any of the products used within this clinical trial;
    2)Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease;
    3)Use of drugs which may interfere with vitamin D metabolism e.g phenobarbital, phenytoin, oral and parenteral glucocorticoids;
    4)Use of any vitamin D supplement alone or in association (multivitamin, vitamin D/calcium combination, vitamin D/biphosphonate combination) within 4 weeks before the screening visit.
    5)UV light solarium used 2 weeks before the screening visit and during the study;
    6)Participation in any other clinical trial with active substances within 2 months of the screening visit;
    7)History of drug and/or alcohol abuse;
    8)Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the percentage of compliant volunteers between volunteers receiving the administration of a once-a-month administration of vitamin D3 (D-CURE®) and those receiving a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®).
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of study
    E.5.2Secondary end point(s)
    •To compare the mean change from baseline (Month 0) in the 25-OH vitamin D serum concentration at the end of the first 6-month period (Month 6)
    •To compare the mean change from Month 6 in the 25-OH vitamin D serum concentration at the end of the second 6-month period (Month 12)
    •To assess treatment preference
    •To assess treatment persistence
    •To assess treatment acceptability
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of study
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    compliance
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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
    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 months12
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 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)
    This is left to the investigator's decision.
    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 Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-17
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