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

This study has been completed.
Sponsor:
Collaborators:
Chonnam National University Hospital
Kangdong Sacred Heart Hospital
Yeungnam University
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
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01259531
First received: December 7, 2010
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Silodosin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Total International prostate symptom score(IPSS) score before and after treatment [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    Assess the improvement of lower urinary tract symptoms with change in Qmax before and after treatment.

  • Voiding score of IPSS before and after treatment [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]
    Assess the improvement of lower urinary tract symptoms with change in post void residual urine volume(PRV) before and after treatment.


Enrollment: 100
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name in Korea : THRUPAS

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259531

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Chonnam National University Hospital
Kangdong Sacred Heart Hospital
Yeungnam University
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
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
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01259531     History of Changes
Other Study ID Numbers: CWP-SDS-403
Study First Received: December 7, 2010
Last Updated: March 28, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
strong
silodosin
benign prostatic hyperplasia
BPH
lower urinary tract symptoms associated with severe BPH

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014