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

A 12-week, Open Label, Multi-center Study to Investigate the Efficacy and Safety of a α1A Adrenoceptor Selective Antagonist Silodosin on Urinary Disturbance Associated With Benign Prostatic Hyperplasia

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Silodosin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin; Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.	Drug: Silodosin; Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.; Other Names: Brand name in Korea : THRUPAS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Collaborators: Chonbuk National University Hospital; Samsung Medical Center; Seoul St. Mary's Hospital; Pusan National University Hospital; Asan Medical Center; Chonnam National University Hospital; Seoul National University Hospital; Korea University Guro Hospital; Yeungnam University Hospital; Kangdong Sacred Heart Hospital
• Investigators: Study Chair: G.S. Park, Prof, Chonnam National Univ.; Principal Investigator: D.Y. Yang, Prof, Kangdong Sacred Heart; Principal Investigator: K.H. Moon, Prof, Yeongnam Univ. Medical; Principal Investigator: N.C. Park, Pusan National Univ. Hospital; Principal Investigator: S.W. Kim, Prof, Seoul National Univ. Hospital; Principal Investigator: S.W. Lee, Prof, Samsung Medical Center; Principal Investigator: S.W. Kim, Prof, Seoul st. mary's hospital; Principal Investigator: D.G. Moon, Prof, Korea Univ. Guro hospital; Principal Investigator: J.K. Park, Prof, Chunbuk National Univ. Hospital; Principal Investigator: T.Y. Ahn, Prof, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: BPH; benign prostatic hyperplasia; silodosin; strong; lower urinary tract symptoms associated with severe BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: CWP-SDS-403