Benign Prostatic Hyperplasia (BPH)Phase 3NCT00224107

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

A Phase 3 study testing Silodosin in people with Benign Prostatic Hyperplasia (BPH), run by Watson Pharmaceuticals at 43 sites in United States.

Completed

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

Official record

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Trial summary

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks. Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: Silodosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 461 participants
Where: 43 sitesUnited States
Study dates: May 2005to Aug 2006
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

Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.

Who cannot join

Medical conditions that would confound the efficacy evaluation.
Medical conditions in which it would be unsafe to use an alpha-blocker.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with this alpha-blocker.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

Study site
Anaheim, California
Study site
Aurora, Colorado
Study site
Aventura, Florida
Study site
Bay Shore, New York
Study site
Bethany, Oklahoma
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Charlotte, North Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Coral Gables, Florida
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Culver City, California
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Dallas, Texas
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Des Moines, Iowa
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Edina, Minnesota
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Garden City, New York
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Greer, South Carolina
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Huntsville, Alabama
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Irvine, California
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La Jolla, California
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Lakewood, Washington
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Lancaster, Pennsylvania
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Las Vegas, Nevada
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Long Beach, California
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Manhasset, New York
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Marietta, Georgia
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Milwaukee, Wisconsin
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Missoula, Montana
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New York, New York
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Newport Beach, California
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Pensacola, Florida
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Peoria, Illinois
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Portland, Oregon
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Saint Joseph, Michigan
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Salisbury, North Carolina
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Salt Lake City, Utah
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San Diego, California
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Staten Island, New York
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Tacoma, Washington
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Tucson, Arizona
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Waterbury, Connecticut
Study site
Wheat Ridge, Colorado
Study site
Williamsville, New York
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Read the detailed description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: Silodosin, Placebo
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SilodosinDrug
Also called Rapaflo
8 mg daily for 12 weeks
PlaceboOther
1 capsule daily for 12 weeks

Study groups in NCT00224107
Study group	Role	What they receive
Silodosin	Experimental	Silodosin 8 mg once daily with food Receives: Drug: Silodosin
placebo	Placebo comparator	Matching Placebo capsule once daily with food Receives: Other: Placebo

What is being measured

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

International Prostate Symptom Score (IPSS)
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Measured: 12 weeks

Secondary outcomes (1)

Maximum Urine Flow Rate (Qmax)
Change from baseline in maximum urine flow rate (Qmax)at Week 12
Measured: 12 weeks

Timeline

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

May 2005Aug 2006

First posted22 Sep 2005 (estimated)
Study startMay 2005
Primary completionAug 2006
Study completionAug 2006

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 (3)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 461 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00224107
Sponsor's protocol ID: SI04009
Status last verified: Jul 2011
First submitted: 14 Sep 2005
Last updated: 12 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16.
PubMed 19371887
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.
PubMed 23234617
Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.
PubMed 21135869

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

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Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
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Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
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Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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The FLOW Registry.
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Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)

All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00224107
Acronym / sponsor ID: SI04009
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 461 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 3 Dec 2009

Clinical summary

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

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Silodosin	Experimental	Drug: SilodosinSilodosin 8 mg once daily with food
placebo	Placebo comparator	Other: PlaceboMatching Placebo capsule once daily with food

Who may qualify

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

Key inclusion criteria (1 listed)

Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.

Key exclusion criteria (4 listed)

Medical conditions that would confound the efficacy evaluation.
Medical conditions in which it would be unsafe to use an alpha-blocker.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with this alpha-blocker.

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
SilodosinAlso: Rapaflo8 mg daily for 12 weeks	Drug	Silodosin
Placebo1 capsule daily for 12 weeks	Other	placebo

Primary outcome

International Prostate Symptom Score (IPSS)
Time frame: 12 weeks
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms

1 secondary outcome

Maximum Urine Flow Rate (Qmax)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 3 Dec 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
Silodosin	233	202
Placebo	228	214

Primary outcome: International Prostate Symptom Score (IPSS)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Units on a 0 to 35 scale

Measure	Silodosin n = 233	Placebo n = 228
Baseline IPSS	21.5 (5.38)	21.4 (4.91)
Change from Baseline in IPSS at Week 12	-6.5 (6.73)	-3.6 (5.85)

Population analysed: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silodosin	3 of 233 (1.3%)	116 of 233 (49.8%)	Not reported
Placebo	3 of 228 (1.3%)	24 of 228 (10.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19371887Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16.
Derived from this study: PubMed 23234617Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.
Derived from this study: PubMed 21135869Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingObservational study
The FLOW Registry.
Benign Prostatic Hyperplasia (BPH)
Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)

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.

Lawrence Hill, PharmD, RPh study director

Watson Pharmaceuticals

43 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 Silodosin in people with Benign Prostatic Hyperplasia (BPH), run by Watson Pharmaceuticals at 43 sites in United States.

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 1 inclusion and 4 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. 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 3 Dec 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?

International Prostate Symptom Score (IPSS) (time frame: 12 weeks). 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 NCT00224107, which also lists 3 linked publications.

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 12 Jul 2011; AzTrials last refreshed its copy on 30 Oct 2026.