Prostatic HyperplasiaPhase 3NCT00368979

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

A Phase 3 study testing Dutasteride in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 26 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients. Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Prostatic Hyperplasia
What is being tested?: Dutasteride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 378 participants
Where: 26 sitesJapan
Study dates: 17 Feb 2006to 6 Dec 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Only subjects who meet all the following criteria during the screening phase will be enrolled in the study.
Diagnosis: BPH
Age: ≥50 years
Gender: Male
Estimated prostate volume ≥30cc (by TRUS)
I-PSS Symptom Score (total of 7 items) ≥8 points

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Maximum flow rate (Qmax) ≤15mL/sec (voided volume measured simultaneously ≤150mL)*[1]
Patients who meet either of the following regarding tamsulosin HCl use:
Patients with tamsulosin HCl use:
Patients who have received tamsulosin HCl continuously for at least 4 weeks and who are likely to continue to take tamsulosin HCl without any change to the dosage and administration of the drug until the end of study treatment.
Patients without tamsulosin HCl use:
Patients who haven't received tamsulosin HCl in the past 4 weeks and who are unlikely to use tamsulosin HCl until the end of study treatment.
Outpatients
Patients who in person have given written consent

Who cannot join

Patients who apply to any of the following criteria during the screening phase will not be enrolled in the study.
Post void residual volume >250mL (by suprapubic ultrasound).
History of AUR within the previous 12 weeks.
Evidence or history of prostate cancer.
PSA >10ng/mL [in patients with PSA >4ng/mL, the presence of prostate cancer should be ruled out by the investigator/subinvestigator. DRE and free/total PSA ratio should be considered, and prostate biopsy be conducted if necessary].
Previous surgery (including balloon dilatation, thermotherapy and stent placement) or minimally invasive techniques for BPH.

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Any causes other than BPH, which may in the judgment of the investigator/subinvestigator, affect evaluation of symptoms or urine flow (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute/chronic prostatitis, acute/chronic urinary tract infection).
History of any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias*[2], congestive heart failure or cerebrovascular accident within the previous 6 months; or diabetes mellitus or peptic ulcer uncontrollable with medical treatment.
Liver function tests (AST, ALT, AL-P) >2 times the upper limit of normal.
Serum cleatinine >1.8mg/dL.
Use of any antiandrogen (e.g., chlormadinone acetate, allylesterenol) for BPH within the previous 12 months.
Use of a1-adrenoceptor blockers excluding tamsulosin HCl (e.g., prazosin HCl, urapidil slow-release capsule formulation, terazosin HCl, naftopidil), plant extract preparations for treatment of BPH (e.g., Eviprostat, cernitin pollen extract), herbal medicines (e.g., hachimi-jio-gan, gosha-jinki-gan), other drugs (e.g., Paraprost), and dietary or herbal supplements (e.g., saw palmetto) for relief of BPH symptoms within the previous 4 weeks.
Use of a-adrenoceptor agonists (e.g., pseudoephedrine, phenyle
[1] Subjects with voided volume <150 mL at Qmax measurement cannot be enrolled in the study and may undergo re-measurement of Qmax before the visit for Week 0 for study entry.
[2] Of "Degree II" according to "Grading of Side Effects (PMSB Notification No. 80 dated June 29, 1992) or equivalent (Appendix 4).

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Japan26 sites

GSK Investigational Site
Chiba, 263-0043
GSK Investigational Site
Chiba, 266-0031
GSK Investigational Site
Chiba, 272-0107
GSK Investigational Site
Fukuoka, 802-0077
GSK Investigational Site
Fukuoka, 810-0001
GSK Investigational Site
Fukuoka, 830-0027
GSK Investigational Site
Hyōgo, 660-0052
GSK Investigational Site
Kanagawa, 215-0021
GSK Investigational Site
Kanagawa, 226-0025
GSK Investigational Site
Kanagawa, 229-1103
GSK Investigational Site
Kanagawa, 245-0015
GSK Investigational Site
Kanagawa, 252-0804
GSK Investigational Site
Kanagawa, 259-1132
GSK Investigational Site
Kyoto, 604-8436
GSK Investigational Site
Ōita, 871-0012
GSK Investigational Site
Ōita, 874-0937
GSK Investigational Site
Osaka, 542-0073
GSK Investigational Site
Osaka, 562-0036
GSK Investigational Site
Osaka, 584-0074
GSK Investigational Site
Tokyo, 130-0026
GSK Investigational Site
Tokyo, 131-0032
GSK Investigational Site
Tokyo, 150-0002
GSK Investigational Site
Tokyo, 152-0001
GSK Investigational Site
Tokyo, 153-0051
GSK Investigational Site
Tokyo, 183-0044
GSK Investigational Site
Tokyo, 186-0011

Other trials in Japan

About this study

Official title: Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteride) in Subjects With Benign Prostatic Hyperplasia.

This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Conditions: Prostatic Hyperplasia
Being tested: Dutasteride, Placebo
Keywords: Benign Prostatic Hyperplasia BPH dutasteride
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
once daily
PlaceboDrug
once daily

Study groups in NCT00368979
Study group	Role	What they receive
Dutasteride	Active comparator	Not described Receives: Drug: Dutasteride
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.
Measured: Baseline and Week 52

Secondary outcomes (4)

Percent Change From Baseline in Prostate Volume at Week 52
Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.
Measured: Baseline and Week 52
Number of Participants With IPSS Improvement From Baseline at Week 52
Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
Measured: Baseline and Week 52
Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52
Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
Measured: Baseline and Week 52
Number of Participants With Qmax Improvement From Baseline at Week 52
Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 20066 Dec 2007

First posted29 Aug 2006 (estimated)
Study start17 Feb 2006
Primary completion1 Dec 2007
Study completion6 Dec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00368979
Sponsor's protocol ID: ARI105326
Status last verified: Aug 2018
First submitted: 24 Aug 2006
Last updated: 26 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol. 2009 Sep;16(9):745-50. doi: 10.1111/j.1442-2042.2009.02357.x. Epub 2009 Aug 5.
PubMed 19674165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
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Recruiting
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All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteride) in Subjects With Benign Prostatic Hyperplasia.
ClinicalTrials.gov ID: NCT00368979
Acronym / sponsor ID: ARI105326
Conditions: Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia BPH dutasteride
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Feb 2006
Primary completion: 1 Dec 2007 (actual)
Study completion: 6 Dec 2007 (actual)
First posted: 29 Aug 2006 (estimated)
Results: Posted 2 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dutasteride	Active comparator	Drug: Dutasteride
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Only subjects who meet all the following criteria during the screening phase will be enrolled in the study.
Diagnosis: BPH
Age: ≥50 years
Gender: Male
Estimated prostate volume ≥30cc (by TRUS)

Key exclusion criteria (15 listed)

Patients who apply to any of the following criteria during the screening phase will not be enrolled in the study.
Post void residual volume >250mL (by suprapubic ultrasound).
History of AUR within the previous 12 weeks.
Evidence or history of prostate cancer.
PSA >10ng/mL [in patients with PSA >4ng/mL, the presence of prostate cancer should be ruled out by the investigator/subinvestigator. DRE and free/total PSA ratio should be considered, and prostate biopsy be conducted if necessary].

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
Dutasterideonce daily	Drug	Dutasteride
Placeboonce daily	Drug	Placebo

Primary outcome

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
Time frame: Baseline and Week 52
The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.

4 secondary outcomes

Percent Change From Baseline in Prostate Volume at Week 52
Time frame: Baseline and Week 52
Number of Participants With IPSS Improvement From Baseline at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52
Time frame: Baseline and Week 52
Number of Participants With Qmax Improvement From Baseline at Week 52
Time frame: Baseline and Week 52

Results and safety

Results posted to the registry on 2 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	185	160
Dutasteride	193	163

Primary outcome: Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52

Time frame: Baseline and Week 52. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 181	Dutasteride n = 184
Value	-3.6 (5.72)	-5.5 (5.94)

Placebo vs Dutasteride: Mean Difference (Net): -1.6 (95% CI -2.7 to -0.5), p = 0.003, ANCOVA

Population analysed: The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	8 of 184 (4.3%)	116 of 184 (63%)	Not reported
Dutasteride	20 of 193 (10.4%)	124 of 193 (64.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19674165Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol. 2009 Sep;16(9):745-50. doi: 10.1111/j.1442-2042.2009.02357.x. Epub 2009 Aug 5.

Related trials for Prostatic Hyperplasia

Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive

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 study director

GlaxoSmithKline

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dutasteride in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 26 sites in Japan.

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 14 inclusion and 15 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: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368979, which also lists 1 linked publication.

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 26 Sep 2018.