Open label phase 4 study of a new formulation of Calcichew D3
Research type
Research Study
Full title
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.
IRAS ID
174334
Contact name
Paul Ivan
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd.
Eudract number
2014-005619-18
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
The proposed study is a randomised, 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. The study will be funded by Takeda.
The purpose of this study is to find out if participants prefer a new formulation of Calcichew D3, codename “CaNew” to 2 comparator products.
Approximately 276 subjects will be included in this study with approximately 138 participants expected to be recruited in the UK and approximately 138 participants expected to be recruited in Germany. The duration of study treatment will be 28 days.
Across both countries, patients will be randomised into two treatment sequences to minimise bias. In test group 1, which will take place in the United Kingdom (UK), subjects will be randomised to receive either CaNew 500/400 bid or Adcal D3 600/400 bid. After two weeks of treatment subjects will cross-over to a further two weeks with the alternate treatment. In test group 2, which will take place in Germany (DE) subjects will be randomised to either CaNew 500/800 q.d. or Kalcipos D 500/800 q.d. After two weeks of treatment subjects will cross-over to a further two weeks with the alternate treatment. Subjects will be asked to complete questionnaires relating to their study medication on Day 14 and Day 28. On Day 28 they will also be asked to indicate whether they have a preference for either of the 2 study medications received.
The study will consist of a screening visit (Days -14 to -1) and two treatment periods (Days 1-14 and Days 15-28).
This study involves procedures including: Physical examinations, vital signs, pregnancy test (if applicable) and questionnaires
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0275
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion