EUCTR2014-005619-18-DE进行中（未招募）不适用
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.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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