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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Silodosin

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Seoul national university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Silodosin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01259531

First Posted

December 7, 2010

Last Updated

March 28, 2012

Sponsor

JW Pharmaceutical

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01259531

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

strong, silodosin, benign prostatic hyperplasia, BPH, lower urinary tract symptoms associated with severe BPH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silodosin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Silodosin

Other Intervention Name(s)

Brand name in Korea : THRUPAS

Intervention Description

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

Primary Outcome Measure Information:

Title

Total International prostate symptom score(IPSS) score before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment.

Time Frame

For 12 weeks

Secondary Outcome Measure Information:

Title

Quality of life(QoL) score before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in QoL score before and after treatment.

Time Frame

For 12 weeks

Title

Maximal urinary flow rate(Qmax) before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment.

Time Frame

For 12 weeks

Title

Voiding score of IPSS before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in voiding scores before and after treatment.

Time Frame

For 12 weeks

Title

Storage scores of IPSS before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in storage scores before and after treatment.

Time Frame

For 12 weeks

Title

Post void residual urine volume(PVR) before and after treatment

Description

Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment.

Time Frame

For 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: