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

This study has been terminated.
(Incomplete information)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00421421
First received: January 11, 2007
Last updated: November 26, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Dutasteride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period [ Time Frame: 24 Weeks ]

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 [ Time Frame: 24 Weeks ]

Estimated Enrollment: 276
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421421

Locations
United Kingdom
GSK Clinical Trials Call Center
Barnet, United Kingdom, EN5 3DJ
GSK Clinical Trials Call Center
Bath, United Kingdom, BA1 1BX
GSK Clinical Trials Call Centre
Birmingham, United Kingdom, B15 2TH
GSK Clinical Trials Call Center
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 Centre
Derby, United Kingdom, DE22 3NE
GSK Clinical Trials Call Center
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, BSc MBBS GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00421421     History of Changes
Other Study ID Numbers: ARI106807
Study First Received: January 11, 2007
Last Updated: November 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Acute Urinary Retention
Benign Prostatic Hyperplasia
Trial Without Catheter

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Urinary Retention
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urination Disorders
Urologic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014