NCT00421421|TerminatedPhase 4

Study Stopped

Incomplete information

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

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.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

ARI106807

Study Type

interventional

Target

276

Locations

1 country

Sites

Timeline

RegisteredJan 2007

StartedMar 2007

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

276

participants targeted

Target at P75+ for phase_4

Geographic Reach

1 country

25 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed

2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed

Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

January 11, 2007

Last Update Submit

November 26, 2007

Conditions

Benign Prostatic Hyperplasia

Keywords

Acute Urinary RetentionBenign Prostatic HyperplasiaTrial Without Catheter

Outcome Measures

Primary Outcomes (1)

Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
24 Weeks

Secondary Outcomes (1)

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

Interventions

DutasterideDRUG

Eligibility Criteria

Age50 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+8 more criteria

Contact the study team to confirm eligibility.