Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Silodosin

• Registration Number: NCT01259531
• Lead Sponsor: JW Pharmaceutical

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silodosin	Silodosin	Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.

Primary Outcome Measures

Name	Time	Method
Total International prostate symptom score(IPSS) score before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Quality of life(QoL) score before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment.
Maximal urinary flow rate(Qmax) before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment.
Voiding score of IPSS before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment.
Storage scores of IPSS before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment.
Post void residual urine volume(PVR) before and after treatment	For 12 weeks	Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment.

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of