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

Primary Purpose

Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Naftopidil
Sponsored by
Dong-A Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Chonnam national university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Naftopidil dose 2

Placebo

Naftopidil dose 1

Arm Description

PO administration

PO administration

PO administration

Outcomes

Primary Outcome Measures

Efficacy(IPSS score change)

Secondary Outcome Measures

Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)

Full Information

First Posted
February 11, 2013
Last Updated
August 11, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01922375
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naftopidil dose 2
Arm Type
Experimental
Arm Description
PO administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PO administration
Arm Title
Naftopidil dose 1
Arm Type
Experimental
Arm Description
PO administration
Intervention Type
Drug
Intervention Name(s)
Naftopidil
Primary Outcome Measure Information:
Title
Efficacy(IPSS score change)
Time Frame
From 0 week(baseline) to 12 week(end of the treatment)
Secondary Outcome Measure Information:
Title
Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)
Time Frame
From 0 week(baseline) to 12 week(end of the treatment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sae-Woong Kim, MD.PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Seok Hyun, Md, PhD
Organizational Affiliation
Gyeongsang National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Du-Geon Moon, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nam-Cheol Park, MD, PhD
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung-Won Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo-Woong Kim, Md, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tai-Young Ahn, Md, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki-Hak Moon, Md, PhD
Organizational Affiliation
Yeongnam University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo-Sik Chung, MD,PhD
Organizational Affiliation
Ewha Womans University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kweon-Sik Min, MD, PhD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Kwan Park, MD, PhD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae Yul Yang Yang, MD, PhD
Organizational Affiliation
Kangdong Sacred Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji- Kan Ryu, MD, PhD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam national university hospital
City
Gwangju
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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