Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg (CAMON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00919477
First received: June 11, 2009
Last updated: January 21, 2013
Last verified: January 2013

June 11, 2009
January 21, 2013
May 2009
March 2012   (final data collection date for primary outcome measure)
Adverse event incidence [ Time Frame: Time since starting Casodex monotherapy, monthly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00919477 on ClinicalTrials.gov Archive Site
  • improvement of prostate cancer using Tumor marker PSA [ Time Frame: Time since starting Casodex monotherapy, monthly ] [ Designated as safety issue: No ]
  • Maintenance of sexual function [ Time Frame: At 3 months since starting Casodex monotherapy, ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Prostate Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
712
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00919477
NIS-OJP-CAS-2009/1, CAS002
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP