Status:
COMPLETED
Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
Lead Sponsor:
JW Pharmaceutical
Collaborating Sponsors:
Chonnam National University Hospital
Kangdong Sacred Heart Hospital
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).
Eligibility Criteria
Inclusion
- Is at least 50 years old
- Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher
- Has a QoL score of 3 or higher
- Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec
- Has a PRV of below 100mL
- Voluntarily decides to participate in this trial and sign with informed consent form
Exclusion
- Has been administered silodosin
- Has been administered an α1A-adrenoceptor blocker within one month
- Has been prescribed antiandrogens except 5α-reductase inhibitors within a year
- Has had phytotherapy within 3 months
- Has had prostatectomy
- Has had intrapelvic radiation therapy
- Has had transurethral microwave hyperthermia of transurethral needle ablation
- Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI).
- Is conducting self-catherterization
- Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
- Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the normal (upper) level
- Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Has experienced allergy to α1 receptor blockers
- Has orthostatic hypotension around the time of Screening Visit
- Has participated in other clinical trials within 8 weeks prior to Screening Visit
- Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual PSA levels)
- Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01259531
Start Date
December 1 2010
End Date
September 1 2011
Last Update
March 30 2012
Active Locations (1)
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1
Seoul national university hospital
Seoul, South Korea