Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH - Full Text View

Purpose

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 safety.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Silodosin Drug: Tamsulosin Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Silodosin

U.S. FDA Resources

Further study details as provided by Recordati Industria Chimica e Farmaceutica S.p.A.:

Primary Outcome Measures:

Change in baseline total score on the International Prostate Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in baseline obstructive subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
change in baseline irritative subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
change in baseline maximum urine flow rate; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	1228
Study Start Date:	May 2006
Study Completion Date:	January 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Silodosin	Drug: Silodosin 8 mg daily for 12 weeks Other Name: KMD3213
Active Comparator: Tamsulosin	Drug: Tamsulosin 0.4 mg daily for 12 weeks Other Name: Omnic
Placebo Comparator: Placebo	Drug: Placebo once daily for 12 weeks

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359905

Locations

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

Sponsors and Collaborators

Recordati Industria Chimica e Farmaceutica S.p.A.

Investigators

Principal Investigator:

Christopher Re Chapple, BSc MD

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

More Information

No publications provided by Recordati Industria Chimica e Farmaceutica S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernández Fernández 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. Epub 2010 Nov 10.

Responsible Party:	Senior Clinical Project Leader, Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier:	NCT00359905 History of Changes
Other Study ID Numbers:	KMD3213-IT-CL 0215
Study First Received:	August 2, 2006
Last Updated:	February 18, 2009
Health Authority:	Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Romania: National Medicines Agency

Keywords provided by Recordati Industria Chimica e Farmaceutica S.p.A.:

Benign prostatic hyperplasia
alpha-blockers

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013