Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia (BPH)

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia

Nocturia

Treatments

Other: 3-days voiding diary

Drug: Silodosin

Other: Laboratory tests

Other: 12 weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT02106182

JW-SDS-406

Details and patient eligibility

About

The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.

Full description

This study is designed as a multi-center, prospective, open-label and single-arm study. Subjects who are willing to provide written informed consent will be enrolled after screening for eligibility criteria. The subjects will be administered with investigational product for 12 weeks and visit as outpatients for evaluation of safety and efficacy at baseline (visit 2) and 4 weeks (visit 3) and 12 weeks (visit 4) after baseline.

Enrollment

135 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males of at least 50 years of age, with current diagnosis of benign prostatic hyperplasia
Symptoms of nocturia evidenced by ≥2 episodes per night in average according to 3-day voiding diary
More than total of 8 points on IPSS and 3 points on QoL
Able to provide written informed consent and to comply with all study procedures

Exclusion criteria

PSA level > 10 ng/㎖ (except patients who had 4 ng/㎖ < PSA level ≤ 10 ng/㎖ 6 months prior to screening and identified as negative from biopsy)
Symptoms of postural hypotension
Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
Severe cardiac disorders or development or diagnosis of vascular disorder (unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, coronary artery bypass graft, etc) 6 months prior to enrollment
Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
Patients with bladder cancer, cystolith or urethral stricture
Patients with neurogenic bladder
History of acute urinary retention
Indwelling catheter or self intermittent catheterization
Patients with pyuria 1 month prior to screening
History of prostatic cancer
History of prostatic surgery
Patients with uncontrolled chronic disease
Alcoholism or sustained drug dependent abuse 1 year prior to screening
Hypersensitivity to α1A-receptor blockers
Administration of following drugs within according periods prior to screening - 2 weeks: Antimuscarinic agents (Tolterodine, Trospium, Solifenacin, Fesoterodine, Propiverine, Oxybutynin, Flavoxate, etc), Anticholinesterase agents (Neostigmine methylsulfate, etc), Cholinergic agonists (Bethanechol Cl, etc), Benign prostatic hyperplasia agents (Tamsulosin HCl, Prazosin HCl, Terazosin HCl, Doxazosin mesylate, Silodosin, Naftopidil, etc), Tricyclic antidepressants (Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Quinupramine, etc), 6 months: 5-α-Reductase Inhibitors (Finasteride, Dutasteride)
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data