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

Sponsored by:	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	Phase III

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Silodosin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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.

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

Primary Outcome Measures:

Change in baseline score on the International Prostate Symptom Score

Secondary Outcome Measures:

Change in baseline obstructive subscore of the International Prostate Symptom Score;
change in baseline irritative subscore of the International Prostate Symptom Score;
change in baseline maximum urine flow rate;
safety

Estimated Enrollment:	1400
Study Start Date:	May 2006
Estimated Study Completion Date:	February 2008

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

Contacts

Contact: Massimo Casi, MD	+39 0248787 ext 456	casi.m@recordati.it
Contact: Silva Antonio, MD	+39 0248787 ext 307	silva.a@recordati.it

Locations

United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital	Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Christopher Re Chapple, BSc MD +44 07768902102 c.r.chapple@sheffield.ac.uk
Contact: Susannah Hulton, RGN +44 0114 2711870 susannah.hulton@sth.nhs.uk
Principal Investigator: Christopher Re Chapple, Bsc MD

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

Study ID Numbers:	KMD3213-IT-CL 0215
Study First Received:	August 2, 2006
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00359905
Health Authority:	Finland: National Agency for Medicines; 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

Study placed in the following topic categories:

Signs and Symptoms
Hyperplasia
Prostatic Diseases

Prostatic Hyperplasia
Tamsulosin
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009