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

Benign Prostatic Hypertrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260129
• Other study ID #: CWP-SDS-401
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: March 28, 2012
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: October 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a-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 5a-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 5a-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Silodosin
Silodosin 8 mg orally, once daily after morning meal
• Silodosin
Silodosin 4 mg orally, twice daily after morning and evening meal

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	I-PSS	Change in I-PSS total score from baseline	12 weeks	No
Secondary	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	No