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

NCT01757769 | Completed Phase 4

• 2 other identifiers: KMD 3213 IT-CL 03762011-000045-20
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Lower urinary tract symptoms; benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months o treatment

Secondary Outcomes (1)

• Change from baseline in IPSS total score

  4, 12, 24 weeks of treatment

Other Outcomes (1)

• Percentage of subjects improving each symptom of the ICS (International Continence Society) male questionnaire as compared to baseline; to evaluate the effect of silodosin on the most frequent and bothersome symptoms

  6 months of treatment

Study Arms (1)

Silodosin

EXPERIMENTAL

Silodosin capsule 8 mg daily for 24 weeks

Drug: Silodosin

Interventions

Silodosin DRUG

8 mg daily for 24 weeks

Silodosin

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (1)

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

Milan, 20132, Italy

Location

Related Publications (14)

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

  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.

  PMID: 19239460 BACKGROUND

• 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.

  PMID: 1279218 BACKGROUND

• 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.

  PMID: 7563343 BACKGROUND

• 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.

  PMID: 19545384 BACKGROUND

• 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.

  PMID: 21109344 BACKGROUND

• 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

  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.

  PMID: 8777617 BACKGROUND

• 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.

  PMID: 10233487 BACKGROUND

• 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.

  PMID: 10859441 BACKGROUND

• 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.

  PMID: 19371887 BACKGROUND

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

  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.

  PMID: 23541338 BACKGROUND

• 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.

  PMID: 9072592 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher R Chapple, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 31, 2012
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

IT (1)