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

Benign Prostatic Hyperplasia Clinical Trial

— STRONG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259531
• Other study ID #: CWP-SDS-403
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2010
• Last updated: March 28, 2012
• Start date: December 2010
• Est. completion date: September 2011

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a1A-adrenoceptor blocker within one month

• Has been prescribed antiandrogens except 5a-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 a1 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 5a-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 5a-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Silodosin
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (11)

Lead Sponsor	Collaborator
JW Pharmaceutical	Asan Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Kangdong Sacred Heart Hospital, Korea University Guro Hospital, Pusan National University Hospital, Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Yeungnam University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No