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

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106182
• Other study ID #: JW-SDS-406
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2014
• Last updated: March 8, 2017
• Start date: January 2, 2014
• Est. completion date: August 1, 2016

Study information

• Verified date: March 2017
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 1, 2016
• Est. primary completion date: March 2, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a1A-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-a-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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Nocturia
• Prostatic Hyperplasia

Intervention

Drug:
• Silodosin

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)
• 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).
• 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St.Mary's Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Pusan Natonal University Hospital	Busan
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Ratio of subjects with = 25% decrease in incidence of nocturia		12 weeks
Secondary	Ratio of subjects with = 25% decrease in IPSS		12 weeks