Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Dutasteride (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, BSc MBBS, Study Director, Affiliation: GlaxoSmithKline
Summary
The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing
relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention
for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of
dutasteride (0. 5mg once daily) following a single episode of AUR followed by successful
Trial Without Catheter compared with placebo.
Clinical Details
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase IV Study to Evaluate the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Daily for 24 Weeks to Reduce The Risk of Acute Urinary Retention Relapse Following Successful Trial Without Catheter.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Secondary outcome: Benign prostatic hyperplasia (BPH) related surgical intervention rates during study IPSS score during study Relationship between length of time of catheter in situ and Intravesical prostatic protrusion measurements on relapse rates
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Able to read, write and understand instructions related to study procedures and able
to give written informed consent
- 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:
- Prostate volume (PV) of less than 30cc and greater than 80cc measured via Trans
Rectal Ultrasound (TRUS) either at time of hospitalisation or as part of the
screening / randomisation visit
- 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
Locations and Contacts
GSK Clinical Trials Call Center, Barnet EN5 3DJ, United Kingdom
GSK Clinical Trials Call Center, Bath BA1 1BX, United Kingdom
GSK Clinical Trials Call Centre, Birmingham B15 2TH, United Kingdom
GSK Clinical Trials Call Center, Bradford BD2 0NA, United Kingdom
GSK Clinical Trials Call Center, Bristol BS2 8HW, United Kingdom
GSK Clinical Trials Call Center, Chester CH2 1UL, United Kingdom
GSK Clinical Trials Call Center, Colchester CO4 5JL, United Kingdom
GSK Clinical Trials Call Center, Crewe CW1 4QJ, United Kingdom
GSK Clinical Trials Call Centre, Derby DE22 3NE, United Kingdom
GSK Clinical Trials Call Center, Edinburgh EH4 2XU, United Kingdom
GSK Clinical Trials Call Center, Glasgow G51 4TF, United Kingdom
GSK Clinical Trials Call Center, Hull HU16 5JQ, United Kingdom
GSK Clinical Trials Call Center, Leeds LS9 7TF, United Kingdom
GSK Clinical Trials Call Center, Leicester LE5 4PW, United Kingdom
GSK Clinical Trials Call Center, London E11 1NR, United Kingdom
GSK Clinical Trials Call Center, Newcastle Upon Tyne NE7 7DN, United Kingdom
GSK Clinical Trials Call Center, Nottingham NG5 1PB, United Kingdom
GSK Clinical Trials Call Center, Oldham OL1 2JH, United Kingdom
GSK Clinical Trials Call Center, Ormskirk L39 2AZ, United Kingdom
GSK Clinical Trials Call Center, Plymouth PL6 8DH, United Kingdom
GSK Clinical Trials Call Center, Stevenage SG1 4AB, United Kingdom
GSK Clinical Trials Call Center, Sunderland SR4 7TP, United Kingdom
GSK Clinical Trials Call Center, Sutton Coldfield B75 7RR, United Kingdom
GSK Clinical Trials Call Center, Torquay TQ2 7AA, United Kingdom
GSK Clinical Trials Call Center, Wakefield WF1 4DG, United Kingdom
Additional Information
Starting date: March 2007
Last updated: November 26, 2007
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