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Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard� 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Depo-Eligard® (Drug)

Phase: N/A

Status: Completed

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Europe B.V.

Summary

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study. There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient. Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.

Clinical Details

Official title: Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Evaluation of tolerability of treatment on a 4 point scale

Secondary outcome:

Occurrence of Adverse Drug Reactions

Investigator satisfaction with treatment

Overall patient's assessment of treatment benefit

Changes in quality of life of subjects as measured by EORTC QLQ-C30

Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule

Efficacy of treatment

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients having been prescribed Depo-Eligard® 7. 5 mg - 22. 5 mg - 45 mg in accordance

with the terms of the marketing authorization.

Locations and Contacts

Site: 38, Liège 4000, Belgium

Site: 14, Antwerpen, Antwerp 2020, Belgium

Site: 4, Antwerpen, Antwerp 2200, Belgium

Site: 5, Antwerpen, Antwerp 2018, Belgium

Site: 8, Antwerpen, Antwerp 2018, Belgium

Site: 9, Antwerpen, Antwerp 2018, Belgium

Site: 33, Merksem, Antwerp 2170, Belgium

Site: 1, Turnhout, Antwerp 2300, Belgium

Site: 13, Brussel, Brussels Capital Region 1090, Belgium

Site: 23, Bruxelles, Brussels Capital Region 1030, Belgium

Site: 24, Uccle, Brussels Capital Region 1180, Belgium

Site: 32, Aalst, East Flanders 9300, Belgium

Site: 34, Dendermonde, East Flanders 9200, Belgium

Site: 11, Gent, East Flanders 9000, Belgium

Site: 17, Oudenaarde, East Flanders 9700, Belgium

Site: 18, Tienen, Flemish Brabant 3300, Belgium

Site: 39, La Louvière, Hainaut 7100, Belgium

Site: 37, Sint Truiden, Limburg 3800, Belgium

Site: 26, Lasne Chapelle Saint Lambert, Walloon Brabant 1380, Belgium

Site: 21, Ieper, West Flanders 8900, Belgium

Site: 20, Izegem, West Flanders 8870, Belgium

Site: 25, Kortijk, West Flanders 8500, Belgium

Site: 31, Oostende, West Flanders 8400, Belgium

Additional Information

Starting date: December 2011
Last updated: January 10, 2014

Page last updated: August 23, 2015

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