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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- None specified
Inclusion and exclusion 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
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Status
Study Complete
Location
GSK Investigational Site
Exeter, Devon, United Kingdom, EX2 5DW
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
Status
Study Complete
Location
GSK Investigational Site
Tauton, Somerset, United Kingdom, TA1 5DA
Status
Study Complete
Location
GSK Investigational Site
Ilkeston, Derbyshire, United Kingdom, DE7 8LN
Status
Study Complete
Location
GSK Investigational Site
Colchester, Essex, United Kingdom, CO4 5JL
Status
Study Complete
Location
GSK Investigational Site
Leytonstone, London, United Kingdom, E11 1NR
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sutton Coldfield, West Midlands, United Kingdom, B75 7RR
Status
Study Complete
Location
GSK Investigational Site
Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M13 9WL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bradford, United Kingdom, BD9 6RJ
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Enfield, Middlesex, United Kingdom, EN2 8JL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Kilbride, United Kingdom, G75 8RG
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Plymouth, Devon, United Kingdom, PL6 8DH
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE5 4PW
Status
Study Complete
Location
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom, SG2 4AB
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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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