Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Study Overview
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Brief Summary
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Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.

Detailed Description
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Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.

Official Title
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Safety and Efficacy of 8mg Once-daily Versus 4mg Twice-daily Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH ; 12-week, Double-blind, Randomized, Comparison, Multi-center Study

Conditions
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Benign Prostatic Hypertrophy

Intervention / Treatment
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* Drug: Silodosin
* Drug: Silodosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria. Outpatients aged 50 or over Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater) Exclusion Criteria: Patients with a residual urinary volume of 200ml or greater Patients with a history of prostatectomy Patients with a history of intrapelvic radiation therapy Patients with a history of prostatic hyperthermia Patients with prostate cancer or suspected prostate cancer Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. UTI Patients conducting self-catheterization Patients with renal impairment (serum creatinine of 3.0 mg/dl or greater) Patients with severe heptic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or with a total bilirubin of 3.0mg/dL or greater or AST/ALT 2.5 times higher than normal level Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months Patients with a history of an allergy to α-blockers Patients with orthostatic hypotension at around screening visit Patients with an experience of other investigational product treatments within 4 weeks form screening visit. Patients with a PSA of 10 or over, Patients with tumor identified by a prostate biopsy with a PSA of 4 or over (For patients taking 5α-reductase inhibitors for more than 3 months are presumed to have double than their actual PSA levels.) Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study Patients who have taken alpha blockers within the 2 weeks from the start of the therapy Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study. Patients disqualified by the investigator.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin 8 mg<br> | Drug: Silodosin<br>* Silodosin 8 mg orally, once daily after morning meal<br>|
| Experimental: Silodosin 4 mg<br> | Drug: Silodosin<br>* Silodosin 4 mg orally, twice daily after morning and evening meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I-PSS | Change in I-PSS total score from baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question | The rate of patients who experience a decrease in I-PSS total score of 25% or higher The rate of patients who experience an improvement of at least 4 in I-PSS total score I-PSS Change in Qmax from baseline The rate of patients who experience an improvement of 30% or over in Qmax Change in the I-PSS voiding and storage scores from baseline Change in QoL score from baseline Change in ICS Male Questionnaire from baseline Patient's goal achievement score Treatment Satisfaction Question | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, silodosin