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

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KSO-0400
KSO-0400
Silodosin
Placebo
Sponsored by
Kissei Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

KSO-0400 Low Dose

KSO-0400 High Dose

Silodosin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in I-PSS Total Score from baseline

Secondary Outcome Measures

Change in I-PSS Sub-score from baseline
Change in QOL Score from baseline
Change in Qmax (maximum urinary flow rate) from baseline

Full Information

First Posted
October 15, 2010
Last Updated
June 30, 2011
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01222650
Brief Title
A Comparative Study of KSO-0400 in BPH Patients With LUTS
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Arm Title
KSO-0400 Low Dose
Arm Type
Experimental
Arm Title
KSO-0400 High Dose
Arm Type
Experimental
Arm Title
Silodosin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KSO-0400
Intervention Type
Drug
Intervention Name(s)
KSO-0400
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in I-PSS Total Score from baseline
Time Frame
Baseline and 12 weeks (LOCF)
Secondary Outcome Measure Information:
Title
Change in I-PSS Sub-score from baseline
Time Frame
Baseline and 12 weeks (LOCF)
Title
Change in QOL Score from baseline
Time Frame
Baseline and 12 weeks (LOCF)
Title
Change in Qmax (maximum urinary flow rate) from baseline
Time Frame
Baseline and 12 weeks (LOCF)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsumi Hontani
Organizational Affiliation
Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Kanto region
Country
Japan

12. IPD Sharing Statement

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

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