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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01260129
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hypertrophy Drug: Silodosin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Primary Completion Date : November 2010
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. I-PSS [ Time Frame: 12 weeks ]
    Change in I-PSS total score from baseline


Secondary Outcome Measures :
  1. I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question [ Time Frame: 12 weeks ]
    • 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260129


Locations
Korea, Republic of
The Catholic Univ., Bucheon ST.Mary's Hospital
Bucheon, Korea, Republic of
Busan National Univ. Hospital
Busan, Korea, Republic of
Konkuk Univ, Chungju Hospital
Chungju, Korea, Republic of
Choongnam National Univ. Hospital
Daejeon, Korea, Republic of
Eulji Univ. Hospital
Daejeon, Korea, Republic of
Chonnam Univ. Hospital
Hwasun, Korea, Republic of
Inha Univ. Hosipital
Incheon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Chungang Univ. Hospital
Seoul, Korea, Republic of
Korea Univ. Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
The Catholic Univ., Seoul ST.Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Jae Seung Paick, ph.D Department of Urology, Seoul National University Hospital
More Information

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01260129     History of Changes
Other Study ID Numbers: CWP-SDS-401
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by JW Pharmaceutical:
BPH
silodosin

Additional relevant MeSH terms:
Hypertrophy
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents