Benign Prostatic HyperplasiaPhase 4NCT00421421
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by GlaxoSmithKline at 25 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- How many people
- 276 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- Mar 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
25 sites in 1 country.
25 sites in 1 country
United Kingdom25 sites
GSK Clinical Trials Call Center
Barnet, EN5 3DJ
GSK Clinical Trials Call Center
Bath, BA1 1BX
GSK Clinical Trials Call Centre
Birmingham, B15 2TH
GSK Clinical Trials Call Center
Bradford, BD2 0NA
GSK Clinical Trials Call Center
Bristol, BS2 8HW
GSK Clinical Trials Call Center
Chester, CH2 1UL
GSK Clinical Trials Call Center
Colchester, CO4 5JL
GSK Clinical Trials Call Center
Crewe, CW1 4QJ
GSK Clinical Trials Call Centre
Derby, DE22 3NE
GSK Clinical Trials Call Center
Edinburgh, EH4 2XU
GSK Clinical Trials Call Center
Glasgow, G51 4TF
GSK Clinical Trials Call Center
Hull, HU16 5JQ
GSK Clinical Trials Call Center
Leeds, LS9 7TF
GSK Clinical Trials Call Center
Leicester, LE5 4PW
GSK Clinical Trials Call Center
London, E11 1NR
GSK Clinical Trials Call Center
Newcastle upon Tyne, NE7 7DN
GSK Clinical Trials Call Center
Nottingham, NG5 1PB
GSK Clinical Trials Call Center
Oldham, OL1 2JH
GSK Clinical Trials Call Center
Ormskirk, L39 2AZ
GSK Clinical Trials Call Center
Plymouth, PL6 8DH
GSK Clinical Trials Call Center
Stevenage, SG1 4AB
GSK Clinical Trials Call Center
Sunderland, SR4 7TP
GSK Clinical Trials Call Center
Sutton Coldfield, B75 7RR
GSK Clinical Trials Call Center
Torquay, TQ2 7AA
GSK Clinical Trials Call Center
Wakefield, WF1 4DG
About this study
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.
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Dutasteride
- Keywords
- Acute Urinary Retention, Benign Prostatic Hyperplasia, Trial Without Catheter
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Measured: 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
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startMar 2007
Why it stopped: Incomplete information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 276 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, BSc MBBS, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421421
- Sponsor's protocol ID
- ARI106807
- Status last verified
- Nov 2007
- First submitted
- 11 Jan 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00421421
- Acronym / sponsor ID
- ARI106807
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Acute Urinary Retention, Benign Prostatic Hyperplasia, Trial Without Catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incomplete information
- Enrolment
- 276 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutasteride | Drug | – |
Primary outcome
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
Time frame: 24 Weeks
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Incomplete information). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, BSc MBBS study director
GlaxoSmithKline
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by GlaxoSmithKline at 25 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Incomplete information). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.