NCT02106182

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturia
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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)
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

Timeline

• Start date: 2014-01-02
• Primary completion: 2016-03-02
• Completion: 2016-08-01
• First posted: 2014-04-08
• Last updated: 2017-03-10

Locations

6 sites across 1 country: South Korea