135
Participants
Start Date
January 2, 2014
Primary Completion Date
March 2, 2016
Study Completion Date
August 1, 2016
Silodosin
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
Bucheon St.Mary's Hospital, Bucheon-si
Ajou University Hospital, Suwon
Pusan Natonal University Hospital, Busan
Eulji University Hospital, Daejeon
Hanyang University Hospital, Seoul
Soon Chun Hyang University Hospital, Seoul
Lead Sponsor
JW Pharmaceutical
INDUSTRY