NCT01222650

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

First QC Date

October 15, 2010

Last Update Submit

June 30, 2011

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Benign Prostatic HyperplasiaI-PSSα1A-AR antagonist

Outcome Measures

Primary Outcomes (1)

  • Change in I-PSS Total Score from baseline

    Baseline and 12 weeks (LOCF)

Secondary Outcomes (3)

  • 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 Arms (4)

KSO-0400 Low Dose

EXPERIMENTAL
Drug: KSO-0400

KSO-0400 High Dose

EXPERIMENTAL
Drug: KSO-0400

Silodosin

EXPERIMENTAL
Drug: Silodosin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KSO-0400DRUG
KSO-0400 Low Dose
SilodosinDRUG
Silodosin
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BPH patients with LUTS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Kanto Region, Japan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Katsumi Hontani

    Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

JP(1)