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

Primary Purpose

Nocturia, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silodosin
Laboratory tests
3-days voiding diary
12 weeks
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Benign prostatic hyperplasia, Nocturia, Silodosin, Thrupas

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Bucheon St.Mary's Hospital
  • Ajou University Hospital
  • Pusan Natonal University Hospital
  • Eulji University Hospital
  • Hanyang University Hospital
  • Soon Chun Hyang University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Silodosin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Ratio of subjects with ≥ 25% decrease in incidence of nocturia
Ratio of subjects with ≥ 25% decrease in IPSS

Full Information

First Posted
March 31, 2014
Last Updated
March 8, 2017
Sponsor
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02106182
Brief Title
Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
Acronym
BPH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2, 2014 (Actual)
Primary Completion Date
March 2, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, Nocturia, Silodosin, Thrupas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silodosin
Arm Type
Experimental
Arm Description
Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Silodosin
Other Intervention Name(s)
Thrupas Cap
Intervention Type
Other
Intervention Name(s)
Laboratory tests
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
3-days voiding diary
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
12 weeks
Primary Outcome Measure Information:
Title
Incidence of nocturia
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change in International Prostate Symptom Score(IPSS) from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in Quality of Life(QoL) scores from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in Overactive Bladder Symptom Score(OABSS) from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline
Description
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.
Time Frame
12 weeks
Title
Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline
Description
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.
Time Frame
12 weeks
Title
Ratio of subjects with ≥ 25% decrease in incidence of nocturia
Time Frame
12 weeks
Title
Ratio of subjects with ≥ 25% decrease in IPSS
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bucheon St.Mary's Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-818
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Pusan Natonal University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital
City
Seoul
ZIP/Postal Code
140-887
Country
Korea, Republic of

12. IPD Sharing Statement

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

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