Last updated: 11/03/2018 00:12:49

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

GSK study ID
103500
Clinicaltrials.gov ID
NCT00316732
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Observational Sutdy to assess the effectiveness of Avodart in subjects with Benign prostatic hyperplasia in day to day clinical practice
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Procedure/surgery: IPSS Questionnaire
  • Procedure/surgery: EQ-5D Questionnaire
    • Enrollment:
    173
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to December 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia).
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hull, United Kingdom, HU16 5JD
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Leeds, United Kingdom, LS1 3EX
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Wakefield, United Kingdom, WF1 4DG
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Exeter, Devon, United Kingdom, EX2 5DW
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, W18 6BJ
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 26 Results

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-19-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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