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

Benign Prostatic Hyperplasia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00421421
• Other study ID #: ARI106807
• Status: Terminated
• Phase: Phase 4
• First received: January 11, 2007
• Last updated: November 26, 2007
• Start date: March 2007

Study information

• Verified date: November 2007
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 276
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Retention

Intervention

Drug:
• Dutasteride

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period		24 Weeks
Secondary	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		24 Weeks