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

Tracking Information

First Received Date ^ICMJE

April 20, 2006

Last Updated Date

October 15, 2008

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

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Procedure: IPSS Questionnaire
Procedure: EQ-5D Questionnaire

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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 ID ^ICMJE

NCT00316732

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

103500, HOR/AVT 001

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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