A Drug Utilization Study of Radium-223 in Sweden

Neoplasms Clinical Trial

Official title:

A Drug Utilization Study of Xofigo Use in Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331303
• Other study ID #: 17399
• Status: Completed
• Phase: N/A
• First received: January 2, 2015
• Last updated: January 22, 2018
• Start date: April 15, 2015
• Est. completion date: December 19, 2017

Study information

• Verified date: January 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients receiving Xofigo in a clinical trial will not be included in this study

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use		Up to 2 years
Primary	Proportion of being women of Xofigo use		Up to 2 years
Primary	Proportion of being children of Xofigo use		Up to 2 years
Primary	Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV		Up to 2 years
Primary	Dosage of Xofigo (kBq/kg)		Up to 2 years
Primary	Proportion of participants of dose outside label recommendation		Up to 2 years

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