Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter

November 26, 2007 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

276

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • GSK Clinical Trials Call Center
      • Bath, United Kingdom, BA1 1BX
        • GSK Clinical Trials Call Center
      • Birmingham, United Kingdom, B15 2TH
        • GSK Clinical Trials Call Centre
      • Bradford, United Kingdom, BD2 0NA
        • GSK Clinical Trials Call Center
      • Bristol, United Kingdom, BS2 8HW
        • GSK Clinical Trials Call Center
      • Chester, United Kingdom, CH2 1UL
        • GSK Clinical Trials Call Center
      • Colchester, United Kingdom, CO4 5JL
        • GSK Clinical Trials Call Center
      • Crewe, United Kingdom, CW1 4QJ
        • GSK Clinical Trials Call Center
      • Derby, United Kingdom, DE22 3NE
        • GSK Clinical Trials Call Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • GSK Clinical Trials Call Center
      • Glasgow, United Kingdom, G51 4TF
        • GSK Clinical Trials Call Center
      • Hull, United Kingdom, HU16 5JQ
        • GSK Clinical Trials Call Center
      • Leeds, United Kingdom, LS9 7TF
        • GSK Clinical Trials Call Center
      • Leicester, United Kingdom, LE5 4PW
        • GSK Clinical Trials Call Center
      • London, United Kingdom, E11 1NR
        • GSK Clinical Trials Call Center
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • GSK Clinical Trials Call Center
      • Nottingham, United Kingdom, NG5 1PB
        • GSK Clinical Trials Call Center
      • Oldham, United Kingdom, OL1 2JH
        • GSK Clinical Trials Call Center
      • Ormskirk, United Kingdom, L39 2AZ
        • GSK Clinical Trials Call Center
      • Plymouth, United Kingdom, PL6 8DH
        • GSK Clinical Trials Call Center
      • Stevenage, United Kingdom, SG1 4AB
        • GSK Clinical Trials Call Center
      • Sunderland, United Kingdom, SR4 7TP
        • GSK Clinical Trials Call Center
      • Sutton Coldfield, United Kingdom, B75 7RR
        • GSK Clinical Trials Call Center
      • Torquay, United Kingdom, TQ2 7AA
        • GSK Clinical Trials Call Center
      • Wakefield, United Kingdom, WF1 4DG
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, BSc MBBS, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI106807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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