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    Summary
    EudraCT Number:2012-005232-29
    Sponsor's Protocol Code Number:PAT12-730DS
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-10
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-005232-29
    A.3Full title of the trial
    Controlled, randomized, four-arm comparative, open label, multi-centric trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily in vitamin D deficient patients
    Kontrollált, randomizált, négykarú összehasonlító, nyilt multicentrikus klinikai vizsgálat a hetente, illetve havonta alkalmazott 7000 NE, és a 30.000 NE D vitamin (kolekalciferol) készítmények hatásosságának összehasonlítására és biztonságosságának meghatározása a naponta egyszer alkalmazott 1000 NE dózishoz képest a D vitamin kezelésre szoruló betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Opne label trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily.
    7000 NE ill. a 30.0000 NE dózisú D vitamin készítmények hatásosságának összehasonlítása és biztonságosságának meghatározása.
    A.4.1Sponsor's protocol code numberPAT12-730DS
    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 SponsorPharma Patent Kft
    B.1.3.4CountryHungary
    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 supportPharma Patent Kft
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Patent Kft
    B.5.2Functional name of contact pointIroda-törzskönyvezés
    B.5.3 Address:
    B.5.3.1Street AddressMeder utca 8.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1138
    B.5.3.4CountryHungary
    B.5.4Telephone number+361630 6182
    B.5.5Fax number+361630 2560
    B.5.6E-mailclinical@pharmapatent.hu
    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 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 name1000 NE kolekalciferol (Vitamin D3)
    D.3.4Pharmaceutical form Film-coated 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 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 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.IMP: 2
    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 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 name30000 NE kolekalciferol (Vitamin D3)
    D.3.4Pharmaceutical form Film-coated 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 INNcholecalciferol 30k
    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 number30000
    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: 3
    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 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 name7000 NE kolekalciferol (Vitamin D3)
    D.3.4Pharmaceutical form Film-coated 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 INNcholecalciferol 7k
    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 number7000
    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: 4
    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 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 name30000 NE kolekalciferol (Vitamin D3)
    D.3.4Pharmaceutical form Film-coated 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 INNcholecalciferol 30k
    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 number30000
    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
    Vitamin D deficiency
    D-vitamin-hiányos állapot
    E.1.1.1Medical condition in easily understood language
    Vitamin D deficiency
    D-vitamin-hiányos állapot
    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 14.1
    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
    Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week or once-a month administered 7000 IU or 30000 IU vitamin D, respectively.
    A napi 1000 NE dózisnak megfelelő, de hetente egyszer alkalmazott 7000 NE, illetve a havonta egyszer alkalmazott 30.000 NE dózisú D vitamin készítmény hatásosságának összehasonlítása a szérum D vitamin (25OHD) koncentráció mérése alapján.
    E.2.2Secondary objectives of the trial
    Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week administered 7000 IU or 30000 IU vitamin D.
    Register and compare the safety parameters for each group.
    A napi 1000 NE és a hetente alkalmazott 30.000 NE D vitamin dózisok összehasonlítása a vér D vitamin (25 OHD) szintek mérése alapján, valamint a kezelések biztonságosságának meghatározása.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age <18 year
    - 25 OHD level < 50 nmol/L (20 ng/ml)
    - female patients in postmenopausa or under continuous contraception allowed to enroll
    - ICF signed
    - 18 évet betöltött életkor,
    - 25 OHD szint < 50 nmol/L (20 ng/ml),
    - nőbetegek esetében megfelelő fogamzásgátlás alkalmazása vagy igazolt postmenopausa,
    - a vizsgálatra vontakozó betegtájékoztatáson résztvett, a beleegyezési nyilatkozatot elfogadta és saját kezűen aláírta, dátumozta.
    E.4Principal exclusion criteria
    - hypercalcaemia/ se Ca levels out of 2.20-2.60 mmol/L range
    - hypercalcaemia (se Ca 2.20-2.60 mmol/l tartományon kívül)
    - emelkedett szérum calcium labor eredmények vagy hypercalaemia tüneteinek jelentkezése az elmúlt egy év alatt,
    - hypercalciuria jelentkezése az elmúlt két év alatt,
    - vesekövesség anamnezise,
    - súlyosfokú vesebetegség (CKD 3 vagy súlyosabb)
    - krónikusan fenálló vagy súlyos betegség, ami jelentős mértékben befolyásolhatja a felszívódás, a D vitamin metabolizmus, a csontok anyagcseréjét,
    - súlyosfokú anyagcserebetegség, metabolikus csontbetegségek a primer korral járó osteoporosis kivételével,
    - jelentős mértékű obesitas, (BMI >35)
    - jelentős felszívódási rendellenesség ami a Ca anyagcserét befolyásolja,
    - szívelégtelenség vagy angina pectoris,
    - közelmúltbeli (<3 hónap traumatológia kezelés, műtét, stb)
    - alkohol vagy gyógyszerabuzus,
    - tervezett műtéti beavatkozás,
    - a vizsgálatot megelőző 2 hónapon belül elkezdett és folyamatosan alkalmazott napi 1000 NE, vagy attól több D vitamin bevitel (gyógyszer vagy táplálékiegészítő)
    - a kezelés idejére tervezett hosszabb ( >5 nap) utazás más napsugárzási paramétekkel jellemzett égövre,
    - a beválasztást megelőző1 hónapban, vagy folyamatosan fenálló rendszeres ( > havi 2 alkalommal) mesterséges UV-B expozició (pl. solarium) kezelés
    - az együtt nem rendelhető gyógyszerek folyamatos szedése
    E.5 End points
    E.5.1Primary end point(s)
    There are 3 independent endpoints set: based on the changes in 25OHD versus to baseline, in each group, and compared to the group of 1000 IU daily dosage applied.
    1000 IU /day vs. 7000 IU/ week, eqv.
    1000 IU/ day vs 30000 IU/ month egv.
    1000 IU /day vs 30000 IU/week: superioirty
    A vizsgálatnak három elsődleges célja van és ez a három cél teljesen függetlennek tekinthető. A D vitamin (25-OHD) és változása a kezelési csoportokban a bázishoz képest, illetve a csoportok összehasonlítása az 1000 NE csoporthoz viszonyítva. Az elsődleges végpont az elsődleges hatásmutató, azaz a 25OHD szint.
    • 1000 NE/nap és 7000 NE/hét: egyenértékűség
    • 1000 NE/nap és 30.000 NE/hónap: egyenértékűség
    • 1000 NE/nap és 30.000 NE/hét: szuperioritás
    Az összehasonlítások nem függetlenek, mert mindegyik esetén ugyanaz a kontroll. A három független cél bármelyike külön is elérhető
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 vs 90 days
    0 vs 90 nap
    E.5.2Secondary end point(s)
    Frequency of Side effects for each group compared to group "A".
    Changes of serum PTH, Ca, urinary Ca in each and between group.
    A kezelés teljes időtartama alatt a csoportonként regisztrált mellékhatások azonosítása és gyakorisága és összehasonlítása az „A” csoporthoz. A szérum PTH, serum kalcium, vizelet kalcium szintek bazishoz viszonyított változása csoportonkénti összehasonlításban.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On 30 and 90 days
    30. és 90. nap elteltével
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    1000 IU kolekalciferol ( Vitamin D3)
    1000 IU cholecalciferol ( Vitamin D3)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    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 years0
    E.8.9.1In the Member State concerned months6
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state84
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-30
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