Benign Prostatic HyperplasiaPhase 3NCT00359905

Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

A Phase 3 study testing Silodosin and Tamsulosin in people with Benign Prostatic Hyperplasia, run by RECORDATI GROUP at 1 site in United Kingdom.

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 the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term… 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?: Silodosin and Tamsulosin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,228 participants
Where: 1 siteUnited Kingdom
Study dates: May 2006to Jan 2008
Phase: Phase 3
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

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
Use of concomitant drugs that would confound the efficacy evaluation
Use of concomitant drugs that would be unsafe with this alpha-blocker

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Sheffield, S10 2JF

Other trials in United Kingdom

About this study

Official title: Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.

Read the detailed description

This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved

Conditions: Benign Prostatic Hyperplasia
Being tested: Silodosin, Tamsulosin, Placebo
Keywords: Benign prostatic hyperplasia, alpha-blockers
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 KMD3213
8 mg daily for 12 weeks
TamsulosinDrug
Also called Omnic
0.4 mg daily for 12 weeks
PlaceboDrug
once daily for 12 weeks

Study groups in NCT00359905
Study group	Role	What they receive
Silodosin	Experimental	Not described Receives: Drug: Silodosin
Tamsulosin	Active comparator	Not described Receives: Drug: Tamsulosin
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 in baseline total score on the International Prostate Symptom Score
Measured: 12 weeks

Secondary outcomes (4)

Change in baseline obstructive subscore of the International Prostate Symptom Score;
Measured: 12 weeks
change in baseline irritative subscore of the International Prostate Symptom Score;
Measured: 12 weeks
change in baseline maximum urine flow rate;
Measured: 12 weeks
safety
Measured: 52 weeks

Timeline

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

May 2006Jan 2008

First posted3 Aug 2006 (estimated)
Study startMay 2006
Primary completionMay 2007
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies 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: 1,228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00359905
Sponsor's protocol ID: KMD3213-IT-CL 0215
Status last verified: Feb 2009
First submitted: 2 Aug 2006
Last updated: 19 Feb 2009
Results posted: No
Data monitoring committee: No

Publications

Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. doi: 10.1007/s00345-015-1519-2. Epub 2015 Feb 25.
PubMed 25712312
Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E; European Silodosin Study Group. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011 Mar;59(3):342-52. doi: 10.1016/j.eururo.2010.10.046. Epub 2010 Nov 10.
PubMed 21109344

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

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.
ClinicalTrials.gov ID: NCT00359905
Acronym / sponsor ID: KMD3213-IT-CL 0215
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, alpha-blockers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,228 participants (actual)
Lead sponsor: RECORDATI GROUPIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: May 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 3 Aug 2006 (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.

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: 3

Arm	Type	Receives
Silodosin	Experimental	Drug: Silodosin
Tamsulosin	Active comparator	Drug: Tamsulosin
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 (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
Use of concomitant drugs that would confound the efficacy evaluation
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: KMD32138 mg daily for 12 weeks	Drug	Silodosin
TamsulosinAlso: Omnic0.4 mg daily for 12 weeks	Drug	Tamsulosin
Placeboonce daily for 12 weeks	Drug	Placebo

Primary outcome

Change in baseline total score on the International Prostate Symptom Score
Time frame: 12 weeks

4 secondary outcomes

Change in baseline obstructive subscore of the International Prostate Symptom Score;
Time frame: 12 weeks
change in baseline irritative subscore of the International Prostate Symptom Score;
Time frame: 12 weeks
change in baseline maximum urine flow rate;
Time frame: 12 weeks
safety
Time frame: 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
Derived from this study: PubMed 25712312Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. doi: 10.1007/s00345-015-1519-2. Epub 2015 Feb 25.
Derived from this study: PubMed 21109344Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E; European Silodosin Study Group. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011 Mar;59(3):342-52. doi: 10.1016/j.eururo.2010.10.046. Epub 2010 Nov 10.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Christopher Re Chapple, BSc MD principal investigator

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

1 site 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 and Tamsulosin in people with Benign Prostatic Hyperplasia, run by RECORDATI GROUP at 1 site 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 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 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 baseline total score on the International Prostate Symptom Score (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 NCT00359905, which also lists 2 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 19 Feb 2009.