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

NCT01259531 | Completed Phase 4

• 1 other identifier: CWP-SDS-403
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Benign Prostatic Hyperplasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life(QoL) score before and after treatment

  For 12 weeks

• Maximal urinary flow rate(Qmax) before and after treatment

  For 12 weeks

• Voiding score of IPSS before and after treatment

  For 12 weeks

• Storage scores of IPSS before and after treatment

  For 12 weeks

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

  For 12 weeks

Study Arms (1)

Silodosin

EXPERIMENTAL

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

Drug: Silodosin

Interventions

Silodosin DRUG

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

Also known as: Brand name in Korea : THRUPAS

Silodosin

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead
• Chonnam National University Hospital: collaborator
• Kangdong Sacred Heart Hospital: collaborator
• Yeungnam University Hospital: collaborator
• Pusan National University Hospital: collaborator
• Seoul National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul St. Mary's Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Chonbuk National University Hospital: collaborator
• Asan Medical Center: collaborator

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• G.S. Park, Prof

  Chonnam National Univ.

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 14, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

KR (1)