check_circleStudy Completed

Neoplasms

Bayer Identifier:

17399

ClinicalTrials.gov Identifier:

NCT02331303

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Drug Utilization Study of Radium-223 in Sweden

Trial purpose

The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study
  • - Patients receiving Xofigo in a clinical trial will not be included in this study

Trial summary

Enrollment Goal
37
Trial Dates
April 2015 - December 2017
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Stockholm, Sweden

Primary Outcome

  • Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Proportion of being women of Xofigo use
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Proportion of being children of Xofigo use
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Dosage of Xofigo (kBq/kg)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Proportion of participants of dose outside label recommendation
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Drug Utilization Study of Xofigo Use in Sweden
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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