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

Sponsor:	Recordati Industria Chimica e Farmaceutica S.p.A.
Information provided by:	Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier:	NCT00359905

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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.

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
Silodosin: Experimental	Drug: Silodosin 8 mg daily for 12 weeks
Tamsulosin: Active Comparator	Drug: Tamsulosin 0.4 mg daily for 12 weeks
Placebo: Placebo Comparator	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

Responsible Party:	Recordati Industria Chimica e Farmaceutica S.p.A. ( Senior Clinical Project Leader )
Study ID Numbers:	KMD3213-IT-CL 0215
Study First Received:	August 2, 2006
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00359905 History of Changes
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:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Genital Diseases, Male

Pharmacologic Actions
Signs and Symptoms
Hyperplasia
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 09, 2010