Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
NCT ID: NCT00421421
Last Updated: 2007-11-27
Study Results
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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TERMINATED
PHASE4
276 participants
INTERVENTIONAL
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Dutasteride
Eligibility Criteria
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Inclusion Criteria
* Able to swallow and retain oral medication
* Had a single, spontaneous episode of AUR related to BPH with a drained volume of between 500 and 1500ml
* Had a successful TWOC (defined as successful if the patient returns to satisfactory voiding within the first 24 hours after catheter removal without re-catheterisation) following 2 - 3 days treatment with alpha blocker (preferably alfuzosin 10mg OD) pre TWOC followed by up to seven days treatment with alpha blocker (preferably alfuzosin 10mg OD) post TWOC.
* Able to be randomised within 7 days of successful TWOC
Exclusion Criteria
* Previous episode of AUR prior to the current episode
* AUR not related to BPH i.e. postoperative retention following major abdominal / pelvis surgery
* Previous prostate or urethral surgery
* Previous positive prostate biopsy
* Any cause other than BPH that may result in urinary symptoms or changes in flow rates.
* Any unstable co-existing medical condition
* Previous 5-ARI use
* Previous alpha blocker treatment other than the study mandated 2 - 3 days pre and up to 7 days post TWOC period with alpha blocker (preferably alfuzosin 10mg OD)
* Use of prohibited meds (e.g. 5ARI's, anabolic steroids including testosterone, drugs with antiandrogenic properties)
* Liver enzymes (ALT, AST, ALP) at time of hospitalisation / screening visit greater than 2 x ULN or bilirubin at time of hospitalisation / screening visit greater than 1.5 x ULN.
* Serum creatinine at time of hospitalisation / screening visit greater than 1.5 x ULN
* Treatment with any other investigational product within 30 days prior to the first dose of study medication
* History or current evidence of alcohol or drug abuse within the last 12 months
* Prostate Specific Antigen (PSA) greater than 20ng/ml
* Use of suprapubic catheterisation after failed urethral catheterisation
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
* Isolated bladder neck disease
* Acute or chronic prostatitis
* Confirmed or suspected urethral stricture
* Known bladder stones
* Clot retention secondary to haematuria of any cause
* Patient unwilling to use a condom during sexual intercourse
50 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Principal Investigators
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GSK Clinical Trials, BSc MBBS
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Barnet, , United Kingdom
GSK Clinical Trials Call Center
Bath, , United Kingdom
GSK Clinical Trials Call Centre
Birmingham, , United Kingdom
GSK Clinical Trials Call Center
Bradford, , United Kingdom
GSK Clinical Trials Call Center
Bristol, , United Kingdom
GSK Clinical Trials Call Center
Chester, , United Kingdom
GSK Clinical Trials Call Center
Colchester, , United Kingdom
GSK Clinical Trials Call Center
Crewe, , United Kingdom
GSK Clinical Trials Call Centre
Derby, , United Kingdom
GSK Clinical Trials Call Center
Edinburgh, , United Kingdom
GSK Clinical Trials Call Center
Glasgow, , United Kingdom
GSK Clinical Trials Call Center
Hull, , United Kingdom
GSK Clinical Trials Call Center
Leeds, , United Kingdom
GSK Clinical Trials Call Center
Leicester, , United Kingdom
GSK Clinical Trials Call Center
London, , United Kingdom
GSK Clinical Trials Call Center
Newcastle upon Tyne, , United Kingdom
GSK Clinical Trials Call Center
Nottingham, , United Kingdom
GSK Clinical Trials Call Center
Oldham, , United Kingdom
GSK Clinical Trials Call Center
Ormskirk, , United Kingdom
GSK Clinical Trials Call Center
Plymouth, , United Kingdom
GSK Clinical Trials Call Center
Stevenage, , United Kingdom
GSK Clinical Trials Call Center
Sunderland, , United Kingdom
GSK Clinical Trials Call Center
Sutton Coldfield, , United Kingdom
GSK Clinical Trials Call Center
Torquay, , United Kingdom
GSK Clinical Trials Call Center
Wakefield, , United Kingdom
Countries
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Other Identifiers
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ARI106807
Identifier Type: -
Identifier Source: org_study_id