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    Clinical Trial Results:
    A Randomized, Open-Label, 2-Way Cross-over, Phase 4 Study to Evaluate Subject Preference and Acceptability of a New Formulation of Calcichew D3 in Adult Patients Eligible for Calcium and Vitamin D Supplementation.

    Summary
    EudraCT number
    2014-005619-18
    Trial protocol
    GB   DE  
    Global end of trial date
    27 Aug 2015

    Results information
    Results version number
    v2(current)
    This version publication date
    18 Nov 2016
    First version publication date
    18 Jun 2016
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Update

    Trial information

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    Trial identification
    Sponsor protocol code
    Calcichew-4001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02457247
    WHO universal trial number (UTN)
    U1111-1166-8818
    Other trial identifiers
    15/NW/0275: NRES
    Sponsors
    Sponsor organisation name
    Takeda Development Center Americas, Inc.
    Sponsor organisation address
    One Takeda Parkway, Deerfield, United States, 60015
    Public contact
    Takeda, Medical Director, Clinical Science, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Scientific contact
    Takeda, Medical Director, Clinical Science, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing 500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500 mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and 800 IU of vitamin D) in Test Group 2.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 138
    Country: Number of subjects enrolled
    Germany: 138
    Worldwide total number of subjects
    276
    EEA total number of subjects
    276
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    19
    From 65 to 84 years
    254
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in the study at 9 investigative sites in the United Kingdom and Germany from 02 June 2015 to 27 August 2015.

    Pre-assignment
    Screening details
    Participants eligible for Vitamin D and Calcium supplements were enrolled equally in 1 of 2 Test Groups to determine the preference between 2 treatments. Group 1: Calcichew D3 500/400 and Adcal-D3 600/400 or Group 2: Calcichew D3 500/800 and Kalcipos-D 500/800.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test Group 1: Sequence AB
    Arm description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Adcal-D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Arm title
    Test Group 1: Sequence BA
    Arm description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Adcal-D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Arm title
    Test Group 2: Sequence CD
    Arm description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Kalcipos-D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily.

    Arm title
    Test Group 2: Sequence DC
    Arm description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Kalcipos-D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily.

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Number of subjects in period 1
    Test Group 1: Sequence AB Test Group 1: Sequence BA Test Group 2: Sequence CD Test Group 2: Sequence DC
    Started
    68
    70
    68
    70
    Completed
    66
    68
    68
    70
    Not completed
    2
    2
    0
    0
         Voluntary Withdrawal
    1
    -
    -
    -
         Significant Protocol Deviation
    1
    1
    -
    -
         Pretreatment Event/Adverse Event
    -
    1
    -
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test Group 1: Sequence AB
    Arm description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Adcal-D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Arm title
    Test Group 1: Sequence BA
    Arm description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Adcal-D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Arm title
    Test Group 2: Sequence CD
    Arm description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Investigational medicinal product name
    Kalcipos-D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily.

    Arm title
    Test Group 2: Sequence DC
    Arm description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Kalcipos-D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily.

    Investigational medicinal product name
    Calcichew D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily.

    Number of subjects in period 2
    Test Group 1: Sequence AB Test Group 1: Sequence BA Test Group 2: Sequence CD Test Group 2: Sequence DC
    Started
    66
    68
    68
    70
    Completed
    64
    65
    68
    70
    Not completed
    2
    3
    0
    0
         Voluntary Withdrawal
    1
    1
    -
    -
         Significant Protocol Deviation
    1
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
         Pretreatment Event/Adverse Event
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test Group 1: Sequence AB
    Reporting group description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 1: Sequence BA
    Reporting group description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence CD
    Reporting group description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence DC
    Reporting group description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.

    Reporting group values
    Test Group 1: Sequence AB Test Group 1: Sequence BA Test Group 2: Sequence CD Test Group 2: Sequence DC Total
    Number of subjects
    68 70 68 70 276
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0 0 8 11 19
        From 65-84 years
    68 69 58 59 254
        85 years and over
    0 1 2 0 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70.9 ± 7.37 70.8 ± 4.94 70.9 ± 7.37 69.9 ± 7.03 -
    Gender categorical
    Units: Subjects
        Female
    40 41 60 60 201
        Male
    28 29 8 10 75
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    1 3 0 1 5
        Multiracial
    0 1 0 0 1
        White
    67 66 68 69 270
    BMI Categorical
    Units: Subjects
        <25 kg/m^2
    11 17 30 27 85
        25 to <30 kg/m^2
    30 29 27 27 113
        ≥30 kg/m^2
    24 24 11 16 75
        Missing
    3 0 0 0 3
    Smoking Status
    Units: Subjects
        Never Smoked
    28 31 41 35 135
        Ex-smoker
    32 33 18 24 107
        Current Smoker
    8 6 9 11 34
    Alcohol Status
    Units: Subjects
        Never Drank
    11 14 10 12 47
        Ex-drinker
    4 10 5 2 21
        Current Drinker
    53 46 53 56 208
    History of Osteoporosis
    Units: Subjects
        Yes
    1 3 28 24 56
        No
    67 67 40 46 220
    History of Fractures in the Last 10 Years
    Units: Subjects
        Yes
    11 10 7 8 36
        No
    57 60 61 62 240
    Region of Enrollment
    Units: Subjects
        United Kingdom
    68 70 0 0 138
        Germany
    0 0 68 70 138
    History of Osteopenia
    Units: Subjects
        Yes
    7 3 7 12 29
        No
    61 67 61 58 247
    Height
    Height data is available for 65, 70, 68 and 70 participants, respectively.
    Units: cm
        arithmetic mean (standard deviation)
    164.4 ± 7.44 165.4 ± 8.95 164 ± 7.73 164.8 ± 7.78 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    78.92 ± 15.383 81.72 ± 23.559 71.44 ± 13.799 73.61 ± 16.34 -
    Body Mass Index (BMI)
    BMI data is available for 65, 70, 68 and 70 participants, respectively.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    29.157 ± 4.7766 29.588 ± 6.571 26.478 ± 4.2362 27.002 ± 5.1081 -

    End points

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    End points reporting groups
    Reporting group title
    Test Group 1: Sequence AB
    Reporting group description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 1: Sequence BA
    Reporting group description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence CD
    Reporting group description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence DC
    Reporting group description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
    Reporting group title
    Test Group 1: Sequence AB
    Reporting group description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 1: Sequence BA
    Reporting group description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence CD
    Reporting group description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.

    Reporting group title
    Test Group 2: Sequence DC
    Reporting group description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.

    Subject analysis set title
    United Kingdom: Calcichew D3 500/400
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    United Kingdom: Adcal-D3
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    Germany: Calcichew D3 500/800
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    Germany: Kalcipos-D
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    United Kingdom: Calcichew D3 500/400
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    United Kingdom: Adcal-D3 Adcal-D3
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    Germany: Calcichew D3 500/800
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    Germany: Kalcipos-D
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Subject analysis set title
    Test Group 1: Total
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.

    Subject analysis set title
    Test Group 2: Total
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.

    Primary: Percentage of Participants with a Preference for Each Treatment within Each Test Group

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    End point title
    Percentage of Participants with a Preference for Each Treatment within Each Test Group [1]
    End point description
    Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D. Population Description: All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.
    End point type
    Primary
    End point timeframe
    Day 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis not reported for this endpoint
    End point values
    Test Group 1: Sequence AB Test Group 1: Sequence BA Test Group 2: Sequence CD Test Group 2: Sequence DC Test Group 1: Total Test Group 2: Total
    Number of subjects analysed
    64
    65
    68
    70
    129
    138
    Units: percentage of participants
    number (not applicable)
        Preference for Calcichew D3
    67.2
    72.3
    61.8
    52.9
    69.8
    57.2
        Preference for Comparator
    28.1
    12.3
    29.4
    37.1
    20.2
    33.3
        No Preference
    4.7
    15.4
    8.8
    10
    10.1
    9.4
    No statistical analyses for this end point

    Secondary: Product Acceptability after each 14 Day Dosing Period within Each Test Group

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    End point title
    Product Acceptability after each 14 Day Dosing Period within Each Test Group
    End point description
    Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect. Population description: The FAS included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Day 14 and Day 28
    End point values
    United Kingdom: Calcichew D3 500/400 United Kingdom: Adcal-D3 Germany: Calcichew D3 500/800 Germany: Kalcipos-D
    Number of subjects analysed
    138
    138
    138
    138
    Units: mm
    least squares mean (standard error)
        Gritty
    19.2 ± 2.18
    24.6 ± 2.18
    28.4 ± 2.28
    27 ± 2.28
        Chalky
    23.2 ± 2.49
    41.1 ± 2.49
    25.9 ± 2.43
    29.9 ± 2.43
        Sweet/Bitter
    32.5 ± 1.74
    34.5 ± 1.74
    34.1 ± 1.67
    38 ± 1.67
        Chew
    8.1 ± 1.62
    18.1 ± 1.62
    12.2 ± 1.77
    19 ± 1.78
        Swallow
    10.8 ± 2.01
    20.5 ± 2
    11 ± 1.88
    19.5 ± 1.89
        Sticky
    6.1 ± 1.22
    10.9 ± 1.22
    8.2 ± 1.16
    8.4 ± 1.16
    No statistical analyses for this end point

    Secondary: Product Tolerability Expressed as the Percentage of Participants who Experience at Least One Treatment-Emergent Adverse Event within each Test Group

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    End point title
    Product Tolerability Expressed as the Percentage of Participants who Experience at Least One Treatment-Emergent Adverse Event within each Test Group
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    United Kingdom: Calcichew D3 500/400 United Kingdom: Adcal-D3 Adcal-D3 Germany: Calcichew D3 500/800 Germany: Kalcipos-D
    Number of subjects analysed
    135
    136
    138
    138
    Units: percentage of participants
        number (not applicable)
    14.8
    9.6
    5.1
    4.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of the study drug to the last dose of study drug (Up to 28 days)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Set included all participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    United Kingdom: Calcichew D3 500/400
    Reporting group description
    Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Reporting group title
    United Kingdom: Adcal-D3
    Reporting group description
    Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.

    Reporting group title
    Germany: Calcichew D3 500/800
    Reporting group description
    Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Reporting group title
    Germany: Kalcipos-D
    Reporting group description
    Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.

    Serious adverse events
    United Kingdom: Calcichew D3 500/400 United Kingdom: Adcal-D3 Germany: Calcichew D3 500/800 Germany: Kalcipos-D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 136 (0.00%)
    0 / 138 (0.00%)
    0 / 138 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 136 (0.00%)
    0 / 138 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    United Kingdom: Calcichew D3 500/400 United Kingdom: Adcal-D3 Germany: Calcichew D3 500/800 Germany: Kalcipos-D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 135 (0.74%)
    5 / 136 (3.68%)
    0 / 138 (0.00%)
    0 / 138 (0.00%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 135 (0.74%)
    5 / 136 (3.68%)
    0 / 138 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    5
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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