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

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hypertrophy
• Intervention / Treatment: Drug: Silodosin; Drug: Silodosin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • The Catholic Univ., Bucheon ST.Mary's Hospital
  • Busan, Korea, Republic of
    • Busan National Univ. Hospital
  • Chungju, Korea, Republic of
    • Konkuk Univ, Chungju Hospital
  • Daejeon, Korea, Republic of
    • Choongnam National Univ. Hospital
  • Daejeon, Korea, Republic of
    • Eulji Univ. Hospital
  • Hwasun, Korea, Republic of
    • Chonnam Univ. Hospital
  • Incheon, Korea, Republic of
    • Inha Univ. Hosipital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Chungang Univ. Hospital
  • Seoul, Korea, Republic of
    • Korea Univ. Hospital
  • Seoul, Korea, Republic of
    • The Catholic Univ., Seoul ST.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin 8 mg	Drug: Silodosin; Silodosin 8 mg orally, once daily after morning meal; Drug: Silodosin; Silodosin 4 mg orally, twice daily after morning and evening meal
Experimental: Silodosin 4 mg	Drug: Silodosin; Silodosin 8 mg orally, once daily after morning meal; Drug: Silodosin; Silodosin 4 mg orally, twice daily after morning and evening meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Jae Seung Paick, ph.D, Department of Urology, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: BPH; silodosin
• Additional Relevant MeSH Terms: Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hypertrophy; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: CWP-SDS-401