Recruitment

Recruitment Status
Completed
Estimated Enrollment
126

Inclusion Criteria

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

Exclusion Criteria

Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
Hypersensitivity to α1A-receptor blockers
Symptoms of postural hypotension
...
Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
Hypersensitivity to α1A-receptor blockers
Symptoms of postural hypotension
History of acute urinary retention
History of prostatic surgery
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
Patients with pyuria 1 month prior to screening
Indwelling catheter or self intermittent catheterization
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)
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
Patients with neurogenic bladder
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)
Patients with uncontrolled chronic disease
Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
Patients with bladder cancer, cystolith or urethral stricture
History of prostatic cancer
Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
Alcoholism or sustained drug dependent abuse 1 year prior to screening

Summary

Conditions
  • Benign Prostatic Hyperplasia
  • Nocturia
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Only males

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 out...

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.

Inclusion Criteria

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

Exclusion Criteria

Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
Hypersensitivity to α1A-receptor blockers
Symptoms of postural hypotension
...
Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
Hypersensitivity to α1A-receptor blockers
Symptoms of postural hypotension
History of acute urinary retention
History of prostatic surgery
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
Patients with pyuria 1 month prior to screening
Indwelling catheter or self intermittent catheterization
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)
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
Patients with neurogenic bladder
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)
Patients with uncontrolled chronic disease
Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
Patients with bladder cancer, cystolith or urethral stricture
History of prostatic cancer
Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
Alcoholism or sustained drug dependent abuse 1 year prior to screening

Tracking Information

NCT #
NCT02106182
Collaborators
Not Provided
Investigators
Not Provided
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