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

A Multi-center, Prospective, Open-label, Single-arm, 12-weeks, Phase IV Trial to Evaluate the Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Nocturia
• Intervention / Treatment: Drug: Silodosin; Other: Laboratory tests; Other: 3-days voiding diary; Other: 12 weeks

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan Natonal University Hospital
  • Daejeon, Korea, Republic of, 302-799
    • Eulji University Hospital
  • Seoul, Korea, Republic of, 133-792
    • Hanyang University Hospital
  • Seoul, Korea, Republic of, 140-887
    • Soon Chun Hyang University Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 420-818
      • Bucheon St.Mary's Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of, 443-380
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Silodosin; Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks

Drug: Silodosin; Other Names: Thrupas Cap; Other: Laboratory tests; Subject's overall health state will be evaluated by clinical laboratory tests. Serum chemistry test: Creatinine, Blood Urea Nitrogen(BUN), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT) Urinalysis: Urine Specific Gravity, Urine pH, Urine Protein, Urine Glucose, Urine Ketone, Urine Bilirubin, Urine Urobilinogen, Urine Nitrite, Urine Occult Blood(OB), Urine Red Blood Cell(RBC), Urine White Blood Cell(WBC) Immunoassay: Prostate Specific Antigen(PSA); Other: 3-days voiding diary; 3-day voiding diaries will be distributed on Visits 1, 2 and 3. Subjects will record incidence of nocturia during 3 days on the diaries within 7 days of Visits 2 (baseline), 3 and 4. The average will be used to confirm the change in incidence of nocturia (at baseline, results from within 1 week from screening may be used but will be excluded for subjects needing wash-out period).; Other: 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of nocturia	Descriptive statistics for incidence of nocturia will be provided for each visit. Paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in International Prostate Symptom Score(IPSS) from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in Quality of Life(QoL) scores from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in Overactive Bladder Symptom Score(OABSS) from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline	Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.	12 weeks
Ratio of subjects with ≥ 25% decrease in incidence of nocturia		12 weeks
Ratio of subjects with ≥ 25% decrease in IPSS		12 weeks

Collaborators and Investigators

• Sponsor: JW Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2014
• Primary Completion (Actual): March 2, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Nocturia; Benign prostatic hyperplasia; Silodosin; Thrupas
• Additional Relevant MeSH Terms: Pathologic Processes; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Nocturia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: JW-SDS-406