Clinical trial NCT01259531: Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: strong
silodosin
benign prostatic hyperplasia
BPH
lower urinary tract symptoms associated with severe BPH
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Chonnam National University Hospital
name: Kangdong Sacred Heart Hospital
name: Yeungnam University Hospital
name: Pusan National University Hospital
name: Seoul National University Hospital
name: Samsung Medical Center
name: Seoul St. Mary's Hospital
name: Korea University Guro Hospital
name: Chonbuk National University Hospital
name: Asan Medical Center
First posted: 2010-12-14
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Total International prostate symptom score(IPSS) score before and after treatment
timeFrame: For 12 weeks
Secondary outcomes:
measure: Quality of life(QoL) score before and after treatment
timeFrame: For 12 weeks
measure: Maximal urinary flow rate(Qmax) before and after treatment
timeFrame: For 12 weeks
measure: Voiding score of IPSS before and after treatment
timeFrame: For 12 weeks
measure: Storage scores of IPSS before and after treatment
timeFrame: For 12 weeks
measure: Post void residual urine volume(PVR) before and after treatment
timeFrame: For 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Chonnam National Univ.
name: G.S. Park, Prof
role: STUDY_CHAIR
affiliation: Kangdong Sacred Heart
name: D.Y. Yang, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeongnam Univ. Medical
name: K.H. Moon, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National Univ. Hospital
name: N.C. Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National Univ. Hospital
name: S.W. Kim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: S.W. Lee, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: S.W. Kim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Univ. Guro Hospital
name: D.G. Moon, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Chunbuk National Univ. Hospital
name: J.K. Park, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: T.Y. Ahn, Prof
role: PRINCIPAL_INVESTIGATOR
References: