Clinical trial NCT00359905: Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
alpha-blockers
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 1228
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in baseline total score on the International Prostate Symptom Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in baseline obstructive subscore of the International Prostate Symptom Score;
timeFrame: 12 weeks
measure: change in baseline irritative subscore of the International Prostate Symptom Score;
timeFrame: 12 weeks
measure: change in baseline maximum urine flow rate;
timeFrame: 12 weeks
measure: safety
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
name: Christopher Re Chapple, BSc MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. doi: 10.1007/s00345-015-1519-2. Epub 2015 Feb 25.
citation: 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.