Last updated: 11/04/2018 04:43:52
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
GSK study ID
ARI106807
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Timeframe: 24 Weeks
Secondary outcomes:
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
Timeframe: 24 Weeks
Interventions:
Enrollment:
276
Primary completion date:
2007-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
None
Study date(s)
March 2007 to March 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Clinical Trials Call Center
Crewe, N/A, United Kingdom, CW1 4QJ
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Wakefield, N/A, United Kingdom, WF1 4DG
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Torquay, N/A, United Kingdom, TQ2 7AA
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Bath, N/A, United Kingdom, BA1 1BX
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Plymouth, N/A, United Kingdom, PL6 8DH
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Leeds, N/A, United Kingdom, LS9 7TF
Status
Terminated/Withdrawn
Showing 1 - 6 of 25 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
2007-31-03
Actual study completion date
2007-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website