A study in patients eligible for Calcium and Vitamin D supplementation to evaluate subject preference and acceptability of a new formulation of Calcichew D3
- Conditions
- Prevention and treatment of vitamin D and calcium deficiency and adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiencyMedDRA version: 18.0Level: LLTClassification code 10031289Term: Osteoporosis, unspecifiedSystem Organ Class: 100000004859MedDRA version: 18.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-005619-18-DE
- Lead Sponsor
- Takeda Development Centre Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 276
Subject eligibility is determined according to the following criteria prior to entry into the study:
1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. The subject is eligible for or currently receiving treatment with calcium and vitamin D supplement as determined by the treating clinician in accordance with local treatment guidelines.
4. Eligible subjects will either be:
a. Subjects aged 65 years or older requiring calcium and vitamin D supplementation for the prevention or treatment of deficiencies, or
b. Subjects aged 18 years or older that require calcium and vitamin D as an adjunct to specific osteoporosis treatment in subjects at risk of calcium and vitamin D deficiencies.
5. The subject is male or female.
6. A female subject of childbearing potential *who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 12 weeks after last dose of study medication. *Definitions and acceptable methods of contraception are defined in Section 9.1.10 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.11 Pregnancy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 221
Any subject who meets any of the following criteria will not qualify for entry into the study:
1. The subject has received Calcichew D3, Adcal-D3 (if the subject is in Test Group 1) or Kalcipos-D (if the subject is in Test Group 2) within the 6 months prior to the first dose of study medication.
2. The subject has received any investigational compound within 30 days prior to Screening.
3. The subject has a disease and/or condition resulting in hypercalcaemia and/or hypercalciuria and for which the study drugs are contraindicated e.g. Zollinger-Ellison syndrome, nephrolithiasis.
4. The subject has any of the contraindications listed in the corresponding Summary of Product Characteristics (SPC) of the study drug that the patient may receive depending on the Test Group: Calcichew D3 or Adcal-D3 (if the subject is in Test Group 1); Calcichew D3 or Kalcipos-D (if the subject is in Test Group 2).
5. The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
6. The subject has a history of hypersensitivity or allergies to the active substances or to any of the excipients in the investigational products.
7. The subject has a history of known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
8. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to compare the preference of CaNew 500/400 (containing 500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600mg of calcium and 400IU of vitamin D) in Test Group 1, and to compare CaNew 500/800 (containing 500mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500mg of calcium and 800IU of vitamin D) in Test Group 2.;Secondary Objective: • To compare the acceptability of CaNew 500/400 with Adcal-D3 <br>• To compare the acceptability of CaNew 500/800 with Kalcipos-D<br>• To compare the tolerability of CaNew 500/400 with Adcal-D3<br>• To compare the tolerability of CaNew 500/800 with Kalcipos-D;Primary end point(s): The primary endpoint will be the percentage of subjects with a preference for each treatment within each Test Group, as assessed by the preference questionnaire on Day 28.;Timepoint(s) of evaluation of this end point: Day 28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Product acceptability after each 14 day dosing period assessed by questionnaire and product tolerability assessed by incidence of adverse events reported after each 14 day dosing period.;Timepoint(s) of evaluation of this end point: After each 14 day dosing period