Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
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ClinicalTrials.gov Identifier: NCT00421421 |
Recruitment Status
:
Terminated
(Incomplete information)
First Posted
: January 12, 2007
Last Update Posted
: November 27, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign Prostatic Hyperplasia | Drug: Dutasteride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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. |
Study Start Date : | March 2007 |

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

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421421
United Kingdom | |
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Barnet, United Kingdom, EN5 3DJ | |
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Bath, United Kingdom, BA1 1BX | |
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Birmingham, United Kingdom, B15 2TH | |
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Bradford, United Kingdom, BD2 0NA | |
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Bristol, United Kingdom, BS2 8HW | |
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Chester, United Kingdom, CH2 1UL | |
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Colchester, United Kingdom, CO4 5JL | |
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Crewe, United Kingdom, CW1 4QJ | |
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Derby, United Kingdom, DE22 3NE | |
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Edinburgh, United Kingdom, EH4 2XU | |
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Glasgow, United Kingdom, G51 4TF | |
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Hull, United Kingdom, HU16 5JQ | |
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Leeds, United Kingdom, LS9 7TF | |
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Leicester, United Kingdom, LE5 4PW | |
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London, United Kingdom, E11 1NR | |
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Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
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Nottingham, United Kingdom, NG5 1PB | |
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Oldham, United Kingdom, OL1 2JH | |
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Ormskirk, United Kingdom, L39 2AZ | |
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Plymouth, United Kingdom, PL6 8DH | |
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Stevenage, United Kingdom, SG1 4AB | |
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Sunderland, United Kingdom, SR4 7TP | |
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Sutton Coldfield, United Kingdom, B75 7RR | |
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Torquay, United Kingdom, TQ2 7AA | |
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Wakefield, United Kingdom, WF1 4DG |
Study Director: | GSK Clinical Trials, BSc MBBS | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00421421 History of Changes |
Other Study ID Numbers: |
ARI106807 |
First Posted: | January 12, 2007 Key Record Dates |
Last Update Posted: | November 27, 2007 |
Last Verified: | November 2007 |
Keywords provided by GlaxoSmithKline:
Acute Urinary Retention Benign Prostatic Hyperplasia Trial Without Catheter |
Additional relevant MeSH terms:
Hyperplasia Prostatic Hyperplasia Urinary Retention Pathologic Processes Prostatic Diseases Genital Diseases, Male Urination Disorders Urologic Diseases |
Dutasteride 5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |