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

Sponsor

Dong-A Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01922375

Collaborator

(none)

411

Enrollment

Location

Arms

Duration (Months)

45.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia	Drug: Naftopidil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

411 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naftopidil dose 2 PO administration	Drug: Naftopidil
Placebo Comparator: Placebo PO administration
Experimental: Naftopidil dose 1 PO administration	Drug: Naftopidil

Arm

Intervention/Treatment

Experimental: Naftopidil dose 2

PO administration

Drug: Naftopidil

Placebo Comparator: Placebo

PO administration

Experimental: Naftopidil dose 1

PO administration

Drug: Naftopidil

Outcome Measures

Primary Outcome Measures

Efficacy(IPSS score change) [From 0 week(baseline) to 12 week(end of the treatment)]

Secondary Outcome Measures

Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ) [From 0 week(baseline) to 12 week(end of the treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonnam national university hospital	Gwangju		Korea, Republic of

Sponsors and Collaborators

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