NCT01222650CompletedPhase 2
A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
Kissei Pharmaceutical Co., Ltd.1 site in 1 country400 target enrollmentStarted: October 18, 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in I-PSS Total Score from baseline
Study Overview
Brief Summary
The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BPH patients with LUTS
Exclusion Criteria
- •Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia
- •Patients with prostate cancer or suspected prostate cancer
- •Patients who have any clinically relevant cardiovascular, hepatic or renal disorder
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
KSO-0400 Low Dose
Experimental
Intervention: KSO-0400 (Drug)
KSO-0400 High Dose
Experimental
Intervention: KSO-0400 (Drug)
Silodosin
Experimental
Intervention: Silodosin (Drug)
Outcomes
Primary Outcomes
Change in I-PSS Total Score from baseline
Time Frame: Baseline and 12 weeks (LOCF)
Secondary Outcomes
- Change in I-PSS Sub-score from baseline(Baseline and 12 weeks (LOCF))
- Change in QOL Score from baseline(Baseline and 12 weeks (LOCF))
- Change in Qmax (maximum urinary flow rate) from baseline(Baseline and 12 weeks (LOCF))
Investigators
Study Sites (1)
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