Clinical trial NCT01260129: Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hypertrophy
Keywords: BPH
silodosin
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 424
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: I-PSS
timeFrame: 12 weeks
Secondary outcomes:
measure: I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic Univ., Bucheon ST.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Busan National Univ. Hospital
city: Chungju
country: Korea, Republic of
facility: Konkuk Univ, Chungju Hospital
city: Daejeon
country: Korea, Republic of
facility: Choongnam National Univ. Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji Univ. Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam Univ. Hospital
city: Incheon
country: Korea, Republic of
facility: Inha Univ. Hosipital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chungang Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ., Seoul ST.Mary's Hospital
Study officials:
affiliation: Department of Urology, Seoul National University Hospital
name: Jae Seung Paick, ph.D
role: PRINCIPAL_INVESTIGATOR
References: