Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
Primary Purpose
Benign Prostatic Hyperplasia
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Dutasteride
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Acute Urinary Retention, Benign Prostatic Hyperplasia, Trial Without Catheter
Eligibility 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
Sites / Locations
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Centre
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Centre
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00421421
Brief Title
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
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 Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
Incomplete information
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Acute Urinary Retention, Benign Prostatic Hyperplasia, Trial Without Catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
276 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Primary Outcome Measure Information:
Title
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
24 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, BSc MBBS
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Bath
ZIP/Postal Code
BA1 1BX
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Centre
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Bradford
ZIP/Postal Code
BD2 0NA
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Centre
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Ormskirk
ZIP/Postal Code
L39 2AZ
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Sutton Coldfield
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
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