Benign Prostatic HyperplasiaPhase 4SiRENCT01757769

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

A Phase 4 study testing Silodosin in people with Benign Prostatic Hyperplasia, run by RECORDATI GROUP at 1 site in Italy.

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

The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials. Read more about this study

Who is it for?: Ages 60 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Silodosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,036 participants
Where: 1 siteItaly
Study dates: May 2011to Aug 2013
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 60 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist;
Male subjects aged 60 years or older;
IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline);
Able to comply with protocol procedures;
Written informed consent obtained before beginning any investigational procedures.

Who cannot join

Hypersensitivity to the active substance or to any of the excipients;
Patients for whom cataract surgery is scheduled;
History of orthostatic hypotension or syncope;
Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula);
Severe hepatic impairment;
Concomitant use of other α-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serrulate/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline);

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Concomitant use with potent cytochrome P450 3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible pharmacokinetic interaction);
Prostate cancer;
History of prostate or bladder neck surgery, including transurethral prostatectomy, TUNA, laser or other minimally invasive therapy;
Active urinary tract infection;
Acute or recurrent prostatitis (more than 3 times in the last year);
History of neurological disease that may affect bladder function;
Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, percutaneous transluminal coronary angioplasty, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
History or current evidence of drug or alcohol abuse within the last 12 months;
Participation in a study involving the administration of an investigational compound within the past 30 days;
Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele
Milan, 20132

Other trials in Italy

About this study

Official title: Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study

The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.

Read the detailed description

The objective of the study is to confirm in a larger and less selected population ("real life conditions") the positive risk-benefit balance observed with silodosin in double-blind, randomised clinical trials.

The following aspects will be evaluated:

the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
the effects on Quality of Life (QoL) due to urinary symptoms
the safety profile
the adherence to therapy
the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.

Conditions: Benign Prostatic Hyperplasia
Being tested: Silodosin
Keywords: Lower urinary tract symptoms, benign prostatic hyperplasia
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

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

SilodosinDrug
8 mg daily for 24 weeks

Study groups in NCT01757769
Study group	Role	What they receive
Silodosin	Experimental	Silodosin capsule 8 mg daily for 24 weeks Receives: Drug: Silodosin

What is being measured

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

The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score)
Measured: 6 months o treatment

Secondary outcomes (1)

Change from baseline in IPSS total score
Measured: 4, 12, 24 weeks of treatment

Timeline

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

May 2011Aug 2013

First posted31 Dec 2012 (estimated)
Study startMay 2011
Primary completionMar 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,036 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01757769
Sponsor's protocol ID: KMD 3213 IT-CL 0376
Other IDs: 2011-000045-20
Acronym: SiRE
Status last verified: Apr 2014
First submitted: 21 Dec 2012
Last updated: 29 Apr 2014
Results posted: No
Data monitoring committee: No

Publications

Armitage P., Berry G., Matthews JNS Statistical Methods In Medical Research, 4th Ed. Wiley Blackwell Science 2001
Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.
PubMed 19239460
Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
PubMed 1279218
Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6.
PubMed 7563343
Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.
PubMed 19545384
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
de la Rosette J, Alivizatos G, Madersbacher S, Rioja Sanz C, Nordling J, Emberton M, Gravas S, Michel MC, Oelke M. Guidelines on benign prostatic hyperplasia. European Association Urolology 2009
Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x.
PubMed 8777617
Donovan JL, Brookes ST, de la Rosette JJ, Peters TJ, Porru D, Kondo A, Dabhoiwala N, Millard R, Bosch R, Nordling J, Matos Ferreira A, Hofner K, Mostafid H, Walter S, Nissenkorn I, Frimodt Moller C, Mendes Silva M, Chapple C, Abrams P. The responsiveness of the ICSmale questionnaire to outcome: evidence from the ICS-'BPH' study. BJU Int. 1999 Feb;83(3):243-8. doi: 10.1046/j.1464-410x.1999.00930.x.
PubMed 10233487
Gisolf KW, van Venrooij GE, Eckhardt MD, Boon TA. Analysis and reliability of data from 24-hour frequency-volume charts in men with lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol. 2000 Jul;38(1):45-52. doi: 10.1159/000020251.
PubMed 10859441
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
Michel M. The Pharmacological profile of the a1A-Adrenoceptor antagonist silodosin. Eur Urol Suppl. 9 (2010) 486 - 490
Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.
PubMed 23541338
Peters TJ, Donovan JL, Kay HE, Abrams P, de la Rosette JJ, Porru D, Thuroff JW. The International Continence Society "Benign Prostatic Hyperplasia" Study: the botherosomeness of urinary symptoms. J Urol. 1997 Mar;157(3):885-9.
PubMed 9072592

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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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
ClinicalTrials.gov ID: NCT01757769
Acronym / sponsor ID: SiRE / KMD 3213 IT-CL 0376
Conditions: Benign Prostatic Hyperplasia
Keywords: Lower urinary tract symptoms, benign prostatic hyperplasia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,036 participants (actual)
Lead sponsor: RECORDATI GROUPIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Mar 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 31 Dec 2012 (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 confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.

Detailed description

The following aspects will be evaluated:

the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
the effects on Quality of Life (QoL) due to urinary symptoms
the safety profile
the adherence to therapy
the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Silodosin	Experimental	Drug: SilodosinSilodosin capsule 8 mg daily for 24 weeks

Who may qualify

Ages: 60 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist;
Male subjects aged 60 years or older;
IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline);
Able to comply with protocol procedures;
Written informed consent obtained before beginning any investigational procedures.

Key exclusion criteria (16 listed)

Hypersensitivity to the active substance or to any of the excipients;
Patients for whom cataract surgery is scheduled;
History of orthostatic hypotension or syncope;
Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula);
Severe hepatic impairment;

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
Silodosin8 mg daily for 24 weeks	Drug	Silodosin

Primary outcome

The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score)
Time frame: 6 months o treatment

1 secondary outcome

Change from baseline in IPSS total score
Time frame: 4, 12, 24 weeks of treatment

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 29 Apr 2014.
BackgroundArmitage P., Berry G., Matthews JNS Statistical Methods In Medical Research, 4th Ed. Wiley Blackwell Science 2001
Background: PubMed 19239460Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.
Background: PubMed 1279218Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
Background: PubMed 7563343Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6.
Background: PubMed 19545384Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.
Background: 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.
Backgroundde la Rosette J, Alivizatos G, Madersbacher S, Rioja Sanz C, Nordling J, Emberton M, Gravas S, Michel MC, Oelke M. Guidelines on benign prostatic hyperplasia. European Association Urolology 2009
Background: PubMed 8777617Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x.
Background: PubMed 10233487Donovan JL, Brookes ST, de la Rosette JJ, Peters TJ, Porru D, Kondo A, Dabhoiwala N, Millard R, Bosch R, Nordling J, Matos Ferreira A, Hofner K, Mostafid H, Walter S, Nissenkorn I, Frimodt Moller C, Mendes Silva M, Chapple C, Abrams P. The responsiveness of the ICSmale questionnaire to outcome: evidence from the ICS-'BPH' study. BJU Int. 1999 Feb;83(3):243-8. doi: 10.1046/j.1464-410x.1999.00930.x.
Background: PubMed 10859441Gisolf KW, van Venrooij GE, Eckhardt MD, Boon TA. Analysis and reliability of data from 24-hour frequency-volume charts in men with lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol. 2000 Jul;38(1):45-52. doi: 10.1159/000020251.
Background: 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.
BackgroundMichel M. The Pharmacological profile of the a1A-Adrenoceptor antagonist silodosin. Eur Urol Suppl. 9 (2010) 486 - 490

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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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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.

Christopher R Chapple, MD study chair

Urology Department, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Silodosin in people with Benign Prostatic Hyperplasia, run by RECORDATI GROUP at 1 site in Italy.

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 16 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 29 Apr 2014. 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 Italy. 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 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?

The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score) (time frame: 6 months o treatment). 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 NCT01757769, which also lists 14 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 29 Apr 2014.