NocturiaPhase 2NCT00793819

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

A Phase 2 study testing silodosin in people with Nocturia and Prostatic Hyperplasia, run by Watson Pharmaceuticals at 27 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

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Nocturia, Prostatic Hyperplasia
What is being tested?: silodosin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: 27 sitesUnited States
Study dates: Jan 2009to Oct 2009
Phase: Phase 2
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 BPH and nocturia (>=2 episodes per night)

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

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Watson Investigational Site
Albuquerque, New Mexico
Watson Investigational Site
Aventura, Florida
Watson Investigational Site
Bala-Cynwyd, Pennsylvania
Watson Investigational Site
Bay Shore, New York
Watson Investigational Site
Bethany, Oklahoma
Watson Investigational Site
Burien, Washington
Watson Investigational Site
Clearwater, Florida
Watson Investigational Site
Coeur d'Alene, Idaho
Watson Investigational Site
Concord, North Carolina
Watson Investigational Site
Greenbelt, Maryland
Watson Investigational Site
Huntsville, Alabama
Watson Investigational Site
Laguna Hills, California
Watson Investigational Site
Las Vegas, Nevada
Watson Investigational Site
Lawrenceville, New Jersey
Watson Investigational Site
Marietta, Georgia
Watson Investigational Site
Missoula, Montana
Watson Investigational Site
Myrtle Beach, South Carolina
Watson Investigational Site
New York, New York
Watson Investigational Site
Omaha, Nebraska
Watson Investigational Site
Orlando, Florida
Watson Investigational Site
Paducah, Kentucky
Watson Investigational Site
Salisbury, North Carolina
Watson Investigational Site
San Diego, California
Watson Investigational Site
Sandy Springs, Georgia
Watson Investigational Site
Troy, Michigan
Watson Investigational Site
West Des Moines, Iowa
Watson Investigational Site
Williamsville, New York

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

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 and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Conditions: Nocturia, Prostatic Hyperplasia
Being tested: silodosin
Keywords: nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia
Medical subject headings: Nocturia, 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
α1-adrenergic antagonist

Study groups in NCT00793819
Study group	Role	What they receive
1 Silodosin	Experimental	Not described Receives: Drug: silodosin
2 Placebo	Placebo comparator	Not described Receives: Drug: silodosin

What is being measured

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

Change in Nocturia Episodes
Measured: 12 weeks

Timeline

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

Jan 2009Oct 2009

First posted19 Nov 2008 (estimated)
Study startJan 2009
Primary completionOct 2009
Study completionOct 2009

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.
Other trials for NocturiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00793819
Sponsor's protocol ID: SI08005
Status last verified: Feb 2012
First submitted: 17 Nov 2008
Last updated: 9 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Safety and Performance of UCon Patch Electrode
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Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
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An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer

All Nocturia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00793819
Acronym / sponsor ID: SI08005
Conditions: Nocturia, Prostatic Hyperplasia
Keywords: nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 9 Mar 2012

Clinical summary

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

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Detailed description

Study design

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

Arm	Type	Receives
1 Silodosin	Experimental	Drug: silodosin
2 Placebo	Placebo comparator	Drug: silodosin

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 BPH and nocturia (>=2 episodes per night)

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: Rapafloα1-adrenergic antagonist	Drug	1 Silodosin, 2 Placebo

Primary outcome

Change in Nocturia Episodes
Time frame: 12 weeks

Results and safety

Results posted to the registry on 9 Mar 2012, 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 8mg	111	97
Placebo	98	89

Primary outcome: Change in Nocturia Episodes

Time frame: 12 weeks. Mean (Standard Deviation). Unit: episodes

Measure	Silodosin 8mg n = 112	Placebo n = 97
Value	-1.2 (1.35)	-1.0 (1.44)

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

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Silodosin 8mg	1 of 111 (0.9%)	39 of 111 (35.1%)	Not reported
Placebo	1 of 98 (1%)	21 of 98 (21.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nocturia

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer

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.

Kim Caramelli, MS study director

Watson Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing silodosin in people with Nocturia and Prostatic Hyperplasia, run by Watson Pharmaceuticals at 27 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 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Mar 2012). 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 in Nocturia Episodes (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 NCT00793819.

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 9 Mar 2012.