NCT01222650
Completed
Phase 2
A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
ConditionsBenign Prostatic Hyperplasia (BPH)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in I-PSS Total Score from baseline
- Status
- Completed
- Last Updated
- 14 years ago
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.
Investigators
Eligibility Criteria
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
Intervention: Placebo
KSO-0400 Low Dose
Intervention: KSO-0400
KSO-0400 High Dose
Intervention: KSO-0400
Silodosin
Intervention: Silodosin
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))
Study Sites (1)
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