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

NCT ID: NCT01757769

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1036 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-08-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silodosin

Silodosin capsule 8 mg daily for 24 weeks

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

8 mg daily for 24 weeks

Interventions

Silodosin

8 mg daily for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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);
• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

RECORDATI GROUP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher R Chapple, MD

Role: STUDY_CHAIR

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

Locations

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

Milan, , Italy

Countries

Italy

References

Armitage P., Berry G., Matthews JNS Statistical Methods In Medical Research, 4th Ed. Wiley Blackwell Science 2001

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19239460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1279218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7563343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19545384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21109344 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 8777617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10233487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10859441 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19371887 (View on PubMed)

Michel M. The Pharmacological profile of the a1A-Adrenoceptor antagonist silodosin. Eur Urol Suppl. 9 (2010) 486 - 490

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23541338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9072592 (View on PubMed)

Other Identifiers

2011-000045-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KMD 3213 IT-CL 0376

Identifier Type: -

Identifier Source: org_study_id