A Comparative Study of KSO-0400 in BPH Patients With LUTS

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Drug: KSO-0400; Drug: Silodosin; Drug: Placebo

• Registration Number: NCT01222650
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KSO-0400 High Dose	KSO-0400	-
Silodosin	Silodosin	-
Placebo	Placebo	-
KSO-0400 Low Dose	KSO-0400	-

Primary Outcome Measures

Name	Time	Method
Change in I-PSS Total Score from baseline	Baseline and 12 weeks (LOCF)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Japan; 🇯🇵 Kanto region, Japan