Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

August 11, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.

The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

411

Phase

  • Phase 4

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

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients aged 4 years or more diagnosed with BPH

Exclusion Criteria:

  • subjects with uncontrolled blood pressure
  • subjects with hepatic or renal dysfunction
  • subjects with prostate cancer
  • Had treatments for BPH using other alpha receptor antagonists within 2 weeks

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Naftopidil dose 2
PO administration
Drug: Naftopidil
PLACEBO_COMPARATOR: Placebo
PO administration
EXPERIMENTAL: Naftopidil dose 1
PO administration
Drug: Naftopidil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy(IPSS score change)
Time Frame: From 0 week(baseline) to 12 week(end of the treatment)
From 0 week(baseline) to 12 week(end of the treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)
Time Frame: From 0 week(baseline) to 12 week(end of the treatment)
From 0 week(baseline) to 12 week(end of the treatment)

Collaborators and Investigators

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

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Sae-Woong Kim, MD.PhD, Seoul St. Mary's Hospital
  • Principal Investigator: Jae-Seok Hyun, Md, PhD, Gyeongsang National University Hospital
  • Principal Investigator: Du-Geon Moon, MD, PhD, Korea University Guro Hospital
  • Principal Investigator: Nam-Cheol Park, MD, PhD, Pusan National University Hospital
  • Principal Investigator: Sung-Won Lee, MD, PhD, Samsung Medical Center
  • Principal Investigator: Soo-Woong Kim, Md, PhD, Seoul National University Hospital
  • Principal Investigator: Tai-Young Ahn, Md, PhD, Asan Medical Center
  • Principal Investigator: Ki-Hak Moon, Md, PhD, Yeongnam University Hospital
  • Principal Investigator: Woo-Sik Chung, MD,PhD, Ewha Womans University Hospital
  • Principal Investigator: Kweon-Sik Min, MD, PhD, Inje University
  • Principal Investigator: Jong Kwan Park, MD, PhD, Chonbuk National University Hospital
  • Principal Investigator: Dae Yul Yang Yang, MD, PhD, Kangdong Sacred Heart Hospital
  • Principal Investigator: Ji- Kan Ryu, MD, PhD, Inha University Hospital

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 Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

August 11, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 11, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLV_BPH_IV-1

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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