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

PHASE4CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

January 2, 2014

Primary Completion Date

March 2, 2016

Study Completion Date

August 1, 2016

Conditions
NocturiaBenign Prostatic Hyperplasia
Interventions
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

Trial Locations (6)

420-818

Bucheon St.Mary's Hospital, Bucheon-si

443-380

Ajou University Hospital, Suwon

602-739

Pusan Natonal University Hospital, Busan

302-799

Eulji University Hospital, Daejeon

133-792

Hanyang University Hospital, Seoul

140-887

Soon Chun Hyang University Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

JW Pharmaceutical

INDUSTRY

NCT02106182 - Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia | Biotech Hunter | Biotech Hunter