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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01260129
First received: October 28, 2010
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Benign Prostatic Hypertrophy
Drug: Silodosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • I-PSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in I-PSS total score from baseline


Secondary Outcome Measures:
  • I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • 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


Enrollment: 424
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Severance Hospital
Seoul, Korea, Republic of
Korea Univ. Hospital
Seoul, Korea, Republic of
The Catholic Univ., Seoul ST.Mary's Hospital
Seoul, Korea, Republic of
Chungang Univ. Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University 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

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01260129     History of Changes
Other Study ID Numbers: CWP-SDS-401
Study First Received: October 28, 2010
Last Updated: March 28, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014