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

June 30, 2011 updated by: Kissei Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto region, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Silodosin
Drug: Silodosin
Experimental: KSO-0400 Low Dose
Drug: KSO-0400
Experimental: KSO-0400 High Dose
Drug: KSO-0400

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in I-PSS Total Score from baseline
Time Frame: Baseline and 12 weeks (LOCF)
Baseline and 12 weeks (LOCF)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in I-PSS Sub-score from baseline
Time Frame: Baseline and 12 weeks (LOCF)
Baseline and 12 weeks (LOCF)
Change in QOL Score from baseline
Time Frame: Baseline and 12 weeks (LOCF)
Baseline and 12 weeks (LOCF)
Change in Qmax (maximum urinary flow rate) from baseline
Time Frame: Baseline and 12 weeks (LOCF)
Baseline and 12 weeks (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Katsumi Hontani, Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSO1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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