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

NCT02106182 | Completed Phase 4 DMC

• 1 other identifier: JW-SDS-406
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 6

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.

Conditions

Nocturia; Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia; Nocturia; Silodosin; Thrupas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean change in International Prostate Symptom Score(IPSS) from baseline

  12 weeks

• Mean change in Quality of Life(QoL) scores from baseline

  12 weeks

• Mean change in Overactive Bladder Symptom Score(OABSS) from baseline

  12 weeks

• Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline

  12 weeks

• Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline

  12 weeks

Study Arms (1)

Silodosin

EXPERIMENTAL

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

Drug: Silodosin; Other: Laboratory tests; Other: 3-days voiding diary; Other: 12 weeks

Interventions

Silodosin DRUG

Also known as: Thrupas Cap

Silodosin

Laboratory tests OTHER

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)

Silodosin

3-days voiding diary OTHER

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).

Silodosin

12 weeks OTHER

Silodosin

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (6)

Bucheon St.Mary's Hospital

Bucheon-si, Gyeonggi-do, 420-818, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Pusan Natonal University Hospital

Busan, 602-739, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Hanyang University Hospital

Seoul, 133-792, South Korea

Location

Soon Chun Hyang University Hospital

Seoul, 140-887, South Korea

Location

MeSH Terms

Conditions

Nocturia; Prostatic Hyperplasia

Interventions

silodosin; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 8, 2014
• Study Start: January 2, 2014
• Primary Completion: March 2, 2016
• Study Completion: August 1, 2016
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

KR (6)