Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00316732

First received: April 20, 2006

Last updated: August 16, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2006

Last Updated Date

August 16, 2012

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00316732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS

Official Title ^ICMJE

An Observational Study to Assess the Effectiveness of Avodart™(Dutasteride)in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice

Brief Summary

This study was designed to assess the effectiveness of dutasteride in the actual clinical practice of prostate assessment clinics in the UK in accordance with best practice over a 12-month period.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Condition ^ICMJE

Benign Prostatic Hyperplasia
Prostatic Hyperplasia

Intervention ^ICMJE

Procedure: IPSS Questionnaire
Procedure: EQ-5D Questionnaire
Other Names:
- EQ-5D Questionnaire
- IPSS Questionnaire

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

530

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia).
Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH.
Patients must only enter the study after the decision to prescribe dutasteride has been undertaken.

Exclusion criteria: None specified

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00316732

Other Study ID Numbers ^ICMJE

103500

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2012

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

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