Trial Outcomes & Findings for Calcichew D3 Preference Study in Participants Eligible for Calcium and Vitamin D Supplementation. (NCT NCT02457247)
NCT ID: NCT02457247
Last Updated: 2016-10-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
276 participants
Primary outcome timeframe
Day 28
Results posted on
2016-10-25
Participant Flow
Participants took part in the study at 9 investigative sites in the United Kingdom and Germany from 02 June 2015 to 27 August 2015.
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.
Participant milestones
| Measure |
Test Group 1: Sequence AB
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.
|
Test Group 1: Sequence BA
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.
|
Test Group 2: Sequence CD
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.
|
Test Group 2: Sequence DC
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.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
68
|
70
|
68
|
70
|
|
Period 1
COMPLETED
|
66
|
68
|
68
|
70
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
0
|
0
|
|
Period 2
STARTED
|
66
|
68
|
68
|
70
|
|
Period 2
COMPLETED
|
64
|
65
|
68
|
70
|
|
Period 2
NOT COMPLETED
|
2
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Group 1: Sequence AB
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.
|
Test Group 1: Sequence BA
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.
|
Test Group 2: Sequence CD
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.
|
Test Group 2: Sequence DC
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.
|
|---|---|---|---|---|
|
Period 1
Pretreatment Event/Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 1
Significant Protocol Deviation
|
1
|
1
|
0
|
0
|
|
Period 1
Voluntary Withdrawal
|
1
|
0
|
0
|
0
|
|
Period 2
Pretreatment Event/Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 2
Significant Protocol Deviation
|
1
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Period 2
Voluntary Withdrawal
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Calcichew D3 Preference Study in Participants Eligible for Calcium and Vitamin D Supplementation.
Baseline characteristics by cohort
| Measure |
Test Group 1: Sequence AB
n=68 Participants
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.
|
Test Group 1: Sequence BA
n=70 Participants
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.
|
Test Group 2: Sequence CD
n=68 Participants
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.
|
Test Group 2: Sequence DC
n=70 Participants
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.
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 7.37 • n=99 Participants
|
70.8 years
STANDARD_DEVIATION 4.94 • n=107 Participants
|
70.9 years
STANDARD_DEVIATION 7.37 • n=206 Participants
|
69.9 years
STANDARD_DEVIATION 7.03 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
|
Age, Customized
<65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
8 participants
n=206 Participants
|
11 participants
n=7 Participants
|
19 participants
n=31 Participants
|
|
Age, Customized
≥65 years
|
68 participants
n=99 Participants
|
70 participants
n=107 Participants
|
60 participants
n=206 Participants
|
59 participants
n=7 Participants
|
257 participants
n=31 Participants
|
|
Age, Customized
Adults (18-64 Years)
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
8 participants
n=206 Participants
|
11 participants
n=7 Participants
|
19 participants
n=31 Participants
|
|
Age, Customized
From 65-84 Years
|
68 participants
n=99 Participants
|
69 participants
n=107 Participants
|
58 participants
n=206 Participants
|
59 participants
n=7 Participants
|
254 participants
n=31 Participants
|
|
Age, Customized
85 Years and Over
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
75 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=99 Participants
|
66 participants
n=107 Participants
|
68 participants
n=206 Participants
|
69 participants
n=7 Participants
|
270 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
68 participants
n=99 Participants
|
70 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
138 participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
68 participants
n=206 Participants
|
70 participants
n=7 Participants
|
138 participants
n=31 Participants
|
|
Height
|
164.4 cm
STANDARD_DEVIATION 7.44 • n=99 Participants
|
165.4 cm
STANDARD_DEVIATION 8.95 • n=107 Participants
|
164.0 cm
STANDARD_DEVIATION 7.73 • n=206 Participants
|
164.8 cm
STANDARD_DEVIATION 7.78 • n=7 Participants
|
NA cm
STANDARD_DEVIATION NA • n=31 Participants
|
|
Weight
|
78.92 kg
STANDARD_DEVIATION 15.383 • n=99 Participants
|
81.72 kg
STANDARD_DEVIATION 23.559 • n=107 Participants
|
71.44 kg
STANDARD_DEVIATION 13.799 • n=206 Participants
|
73.61 kg
STANDARD_DEVIATION 16.340 • n=7 Participants
|
NA kg
STANDARD_DEVIATION NA • n=31 Participants
|
|
Body Mass Index (BMI)
|
29.157 kg/m^2
STANDARD_DEVIATION 4.7766 • n=99 Participants
|
29.588 kg/m^2
STANDARD_DEVIATION 6.5710 • n=107 Participants
|
26.478 kg/m^2
STANDARD_DEVIATION 4.2362 • n=206 Participants
|
27.002 kg/m^2
STANDARD_DEVIATION 5.1081 • n=7 Participants
|
NA kg/m^2
STANDARD_DEVIATION NA • n=31 Participants
|
|
BMI Categorical
<25 kg/m^2
|
11 participants
n=99 Participants
|
17 participants
n=107 Participants
|
30 participants
n=206 Participants
|
27 participants
n=7 Participants
|
85 participants
n=31 Participants
|
|
BMI Categorical
25 to <30 kg/m^2
|
30 participants
n=99 Participants
|
29 participants
n=107 Participants
|
27 participants
n=206 Participants
|
27 participants
n=7 Participants
|
113 participants
n=31 Participants
|
|
BMI Categorical
≥30 kg/m^2
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
11 participants
n=206 Participants
|
16 participants
n=7 Participants
|
75 participants
n=31 Participants
|
|
BMI Categorical
Missing
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Smoking Status
Never Smoked
|
28 participants
n=99 Participants
|
31 participants
n=107 Participants
|
41 participants
n=206 Participants
|
35 participants
n=7 Participants
|
135 participants
n=31 Participants
|
|
Smoking Status
Ex-smoker
|
32 participants
n=99 Participants
|
33 participants
n=107 Participants
|
18 participants
n=206 Participants
|
24 participants
n=7 Participants
|
107 participants
n=31 Participants
|
|
Smoking Status
Current Smoker
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
11 participants
n=7 Participants
|
34 participants
n=31 Participants
|
|
Alcohol Status
Never Drank
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
10 participants
n=206 Participants
|
12 participants
n=7 Participants
|
47 participants
n=31 Participants
|
|
Alcohol Status
Ex-drinker
|
4 participants
n=99 Participants
|
10 participants
n=107 Participants
|
5 participants
n=206 Participants
|
2 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Alcohol Status
Current Drinker
|
53 participants
n=99 Participants
|
46 participants
n=107 Participants
|
53 participants
n=206 Participants
|
56 participants
n=7 Participants
|
208 participants
n=31 Participants
|
|
History of Osteoporosis
Yes
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
28 participants
n=206 Participants
|
24 participants
n=7 Participants
|
56 participants
n=31 Participants
|
|
History of Osteoporosis
No
|
67 participants
n=99 Participants
|
67 participants
n=107 Participants
|
40 participants
n=206 Participants
|
46 participants
n=7 Participants
|
220 participants
n=31 Participants
|
|
History of Osteopenia
Yes
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
12 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
History of Osteopenia
No
|
61 participants
n=99 Participants
|
67 participants
n=107 Participants
|
61 participants
n=206 Participants
|
58 participants
n=7 Participants
|
247 participants
n=31 Participants
|
|
History of Fractures in the Last 10 Years
Yes
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
7 participants
n=206 Participants
|
8 participants
n=7 Participants
|
36 participants
n=31 Participants
|
|
History of Fractures in the Last 10 Years
No
|
57 participants
n=99 Participants
|
60 participants
n=107 Participants
|
61 participants
n=206 Participants
|
62 participants
n=7 Participants
|
240 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.
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.
Outcome measures
| Measure |
Test Group 1: Sequence AB
n=64 Participants
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.
|
Test Group 1: Sequence BA
n=65 Participants
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.
|
Test Group 2: Sequence CD
n=68 Participants
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.
|
Test Group 2: Sequence DC
n=70 Participants
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.
|
Test Group 1: Total
n=129 Participants
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.
|
Test Group 2: Total
n=138 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Preference for Each Treatment Within Each Test Group
Preference for Calcichew D3
|
67.2 percentage of participants
|
72.3 percentage of participants
|
61.8 percentage of participants
|
52.9 percentage of participants
|
69.8 percentage of participants
|
57.2 percentage of participants
|
|
Percentage of Participants With a Preference for Each Treatment Within Each Test Group
Preference for Comparator
|
28.1 percentage of participants
|
12.3 percentage of participants
|
29.4 percentage of participants
|
37.1 percentage of participants
|
20.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With a Preference for Each Treatment Within Each Test Group
No Preference
|
4.7 percentage of participants
|
15.4 percentage of participants
|
8.8 percentage of participants
|
10.0 percentage of participants
|
10.1 percentage of participants
|
9.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 14 and Day 28Population: The FAS included all randomized participants.
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.
Outcome measures
| Measure |
Test Group 1: Sequence AB
n=138 Participants
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.
|
Test Group 1: Sequence BA
n=138 Participants
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.
|
Test Group 2: Sequence CD
n=138 Participants
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.
|
Test Group 2: Sequence DC
n=138 Participants
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.
|
Test Group 1: Total
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.
|
Test Group 2: Total
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.
|
|---|---|---|---|---|---|---|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Gritty
|
19.2 mm
Standard Error 2.18
|
24.6 mm
Standard Error 2.18
|
28.4 mm
Standard Error 2.28
|
27.0 mm
Standard Error 2.28
|
—
|
—
|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Swallow
|
10.8 mm
Standard Error 2.01
|
20.5 mm
Standard Error 2.00
|
11.0 mm
Standard Error 1.88
|
19.5 mm
Standard Error 1.89
|
—
|
—
|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Chalky
|
23.2 mm
Standard Error 2.49
|
41.1 mm
Standard Error 2.49
|
25.9 mm
Standard Error 2.43
|
29.9 mm
Standard Error 2.43
|
—
|
—
|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Sweet/Bitter
|
32.5 mm
Standard Error 1.74
|
34.5 mm
Standard Error 1.74
|
34.1 mm
Standard Error 1.67
|
38.0 mm
Standard Error 1.67
|
—
|
—
|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Chew
|
8.1 mm
Standard Error 1.62
|
18.1 mm
Standard Error 1.62
|
12.2 mm
Standard Error 1.77
|
19.0 mm
Standard Error 1.78
|
—
|
—
|
|
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Sticky
|
6.1 mm
Standard Error 1.22
|
10.9 mm
Standard Error 1.22
|
8.2 mm
Standard Error 1.16
|
8.4 mm
Standard Error 1.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Test Group 1: Sequence AB
n=135 Participants
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.
|
Test Group 1: Sequence BA
n=136 Participants
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.
|
Test Group 2: Sequence CD
n=138 Participants
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.
|
Test Group 2: Sequence DC
n=138 Participants
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.
|
Test Group 1: Total
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.
|
Test Group 2: Total
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.
|
|---|---|---|---|---|---|---|
|
Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group
|
14.8 percentage of participants
|
9.6 percentage of participants
|
5.1 percentage of participants
|
4.3 percentage of participants
|
—
|
—
|
Adverse Events
United Kingdom: Calcichew D3 500/400
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
United Kingdom: Adcal-D3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Germany: Calcichew D3 500/800
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Germany: Kalcipos-D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
United Kingdom: Calcichew D3 500/400
n=135 participants at risk
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.
|
United Kingdom: Adcal-D3
n=136 participants at risk
Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
|
Germany: Calcichew D3 500/800
n=138 participants at risk
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.
|
Germany: Kalcipos-D
n=138 participants at risk
Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.74%
1/135 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
0.00%
0/136 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
0.00%
0/138 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
0.00%
0/138 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
Other adverse events
| Measure |
United Kingdom: Calcichew D3 500/400
n=135 participants at risk
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.
|
United Kingdom: Adcal-D3
n=136 participants at risk
Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
|
Germany: Calcichew D3 500/800
n=138 participants at risk
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.
|
Germany: Kalcipos-D
n=138 participants at risk
Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/135 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
3.7%
5/136 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
0.00%
0/138 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
0.00%
0/138 • From first dose of the study drug to the last dose of study drug (Up to 28 days)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER