NCT01260129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

October 28, 2010

Last Update Submit

March 28, 2012

Conditions

Benign Prostatic Hypertrophy

Keywords

BPHsilodosin

Outcome Measures

Primary Outcomes (1)

  • I-PSS

    Change in I-PSS total score from baseline

    12 weeks

Secondary Outcomes (1)

  • I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question

    12 weeks

Study Arms (2)

Silodosin 8 mg

EXPERIMENTAL
Drug: Silodosin

Silodosin 4 mg

EXPERIMENTAL
Drug: Silodosin

Interventions

SilodosinDRUG

Silodosin 8 mg orally, once daily after morning meal

Silodosin 8 mg

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

The Catholic Univ., Bucheon ST.Mary's Hospital

Bucheon-si, South Korea

Location

Busan National Univ. Hospital

Busan, South Korea

Location

Konkuk Univ, Chungju Hospital

Chungju, South Korea

Location

Choongnam National Univ. Hospital

Daejeon, South Korea

Location

Eulji Univ. Hospital

Daejeon, South Korea

Location

Chonnam Univ. Hospital

Hwasun, South Korea

Location

Inha Univ. Hosipital

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chungang Univ. Hospital

Seoul, South Korea

Location

Korea Univ. Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic Univ., Seoul ST.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jae Seung Paick, ph.D

    Department of Urology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2010

First Posted

December 15, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Study Completion

October 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

KR(14)