Observational AVODART (Dutasteride) Study In Benign Prost... | NCT00316732 | Trialant

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Observational AVODART (Dutasteride) Study In Benign Prost... | NCT00316732 | Trialant

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

NCT00316732

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 16, 2017Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Prostatic Hyperplasia

Interventions

IPSS Questionnaire
EQ-5D Questionnaire

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00316732

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

103500

Secondary IDs

Not provided

Brief Title

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

Official Title

Observational Sutdy to Assess the Effectiveness of Avodart in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice

Acronym

Not provided

Organization

GlaxoSmithKlineINDUSTRY

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Oct 25, 2004Actual

Primary Completion Date

Dec 19, 2006Actual

Completion Date

Dec 19, 2006Actual

First Submitted Date

Apr 20, 2006

First Submission Date that Met QC Criteria

Apr 20, 2006

First Posted Date

Apr 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2017

Last Update Posted Date

Oct 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

GlaxoSmithKlineINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

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

Not provided

Conditions Module

Conditions

Prostatic Hyperplasia

Keywords

Avodart
IPSS
BPH
dutasteride
EQ-5D
Observational

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPSS Questionnaire	Procedure
EQ-5D Questionnaire	Procedure			IPSS Questionnaire

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

No

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Exeter	Devon	EX2 5DW	United Kingdom
GSK Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Plymouth

Devon

PL6 8DH

United Kingdom

GSK Investigational Site

Colchester

Essex

CO4 5JL

United Kingdom

GSK Investigational Site

Stevenage

Hertfordshire

SG2 4AB

United Kingdom

GSK Investigational Site

Manchester

Lancashire

M13 9WL

United Kingdom

GSK Investigational Site

Manchester

Lancashire

M8 5RB

United Kingdom

GSK Investigational Site

Leicester

Leicestershire

LE5 4PW

United Kingdom

GSK Investigational Site

Leytonstone

London

E11 1NR

United Kingdom

GSK Investigational Site

Enfield

Middlesex

EN2 8JL

United Kingdom

GSK Investigational Site

Nottingham

Nottinghamshire

NG5 1PB

United Kingdom

GSK Investigational Site

Tauton

Somerset

TA1 5DA

United Kingdom

GSK Investigational Site

Sunderland

Tyne & Wear

SR4 7TP

United Kingdom

GSK Investigational Site

Sutton Coldfield

West Midlands

B75 7RR

United Kingdom

GSK Investigational Site

Birmingham

B15 2TH

United Kingdom

GSK Investigational Site

Bradford

BD5 0NA

United Kingdom

GSK Investigational Site

Bradford

BD9 6RJ

United Kingdom

GSK Investigational Site

Bristol

BS2 8HW

United Kingdom

GSK Investigational Site

East Kilbride

G75 8RG

United Kingdom

GSK Investigational Site

Hull

HU16 5JD

United Kingdom

GSK Investigational Site

Ilkeston, Derbyshire

DE7 8LN

United Kingdom

GSK Investigational Site

Leeds

LS1 3EX

United Kingdom

GSK Investigational Site

London

EC1 7BE

United Kingdom

GSK Investigational Site

London

NW3 2QG

United Kingdom

GSK Investigational Site

London

W18 6BJ

United Kingdom

GSK Investigational Site

Sheffield

S10 2JF

United Kingdom

GSK Investigational Site

Torquay

TQ2 7AA

United Kingdom

GSK Investigational Site

Wakefield

WF1 4DG

United Kingdom

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided