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

NCT ID: NCT00316732

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-25

Study Completion Date

2006-12-19

Brief Summary

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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

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Conditions

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Prostatic Hyperplasia

Keywords

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Avodart IPSS BPH dutasteride EQ-5D Observational

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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IPSS Questionnaire

Intervention Type PROCEDURE

EQ-5D Questionnaire

Intervention Type PROCEDURE

Other Intervention Names

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IPSS Questionnaire

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Exeter, Devon, United Kingdom

Site Status

GSK Investigational Site

Plymouth, Devon, United Kingdom

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Colchester, Essex, United Kingdom

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Stevenage, Hertfordshire, United Kingdom

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Manchester, Lancashire, United Kingdom

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Manchester, Lancashire, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Leytonstone, London, United Kingdom

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Enfield, Middlesex, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Tauton, Somerset, United Kingdom

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Sunderland, Tyne & Wear, United Kingdom

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Sutton Coldfield, West Midlands, United Kingdom

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Birmingham, , United Kingdom

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Bradford, , United Kingdom

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Bradford, , United Kingdom

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Bristol, , United Kingdom

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East Kilbride, , United Kingdom

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Hull, , United Kingdom

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Ilkeston, Derbyshire, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Sheffield, , United Kingdom

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GSK Investigational Site

Torquay, , United Kingdom

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GSK Investigational Site

Wakefield, , United Kingdom

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Countries

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United Kingdom

Other Identifiers

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103500

Identifier Type: -

Identifier Source: org_study_id