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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00316732

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia Prostatic Hyperplasia	Procedure: IPSS Questionnaire Procedure: EQ-5D Questionnaire	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	530
Study Start Date:	October 2004

Intervention Details:

Other Names:

EQ-5D Questionnaire
IPSS Questionnaire

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316732

Locations

United Kingdom
GSK Investigational Site
Exeter, Devon, United Kingdom, EX2 5DW
GSK Investigational Site
Plymouth, Devon, United Kingdom, PL6 8DH
GSK Investigational Site
Colchester, Essex, United Kingdom, CO4 5JL
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom, SG2 4AB
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M13 9WL
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE5 4PW
GSK Investigational Site
Leytonstone, London, United Kingdom, E11 1NR
GSK Investigational Site
Enfield, Middlesex, United Kingdom, EN2 8JL
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
GSK Investigational Site
Tauton, Somerset, United Kingdom, TA1 5DA
GSK Investigational Site
Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
GSK Investigational Site
Sutton Coldfield, West Midlands, United Kingdom, B75 7RR
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH
GSK Investigational Site
Bradford, United Kingdom, BD5 0NA
GSK Investigational Site
Bristol, United Kingdom, BS2 8HW
GSK Investigational Site
Hull, United Kingdom, HU16 5JD
GSK Investigational Site
Ilkeston, Derbyshire, United Kingdom, DE7 8LN
GSK Investigational Site
Leeds, United Kingdom, LS1 3EX
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
London, United Kingdom, EC1 7BE
GSK Investigational Site
London, United Kingdom, W18 6BJ
GSK Investigational Site
Torquay, United Kingdom, TQ2 7AA
GSK Investigational Site
Wakefield, United Kingdom, WF1 4DG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00316732 History of Changes
Other Study ID Numbers:	103500
Study First Received:	April 20, 2006
Last Updated:	January 12, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Avodart
IPSS
BPH

dutasteride
EQ-5D
Observational

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012