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MIrabegron With oveRACtive bLadder Symptoms in mEn

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mirabegron
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male aged 20 years
  • Patients with an average of at least 8 micturitions per 24 hours in last 3 days based on the micturition diary
  • Patients with an average of at least 1 episode of urgency per 24 hours in last 3 days based on the micturition diary
  • Patients who have symptoms of OAB for at least 12 weeks prior to the enrollment
  • Patients who are able to complete the micturition diary and questionnaires correctly
  • Patients who provided a singed consent form after being informed of the nature of the study and risk and benefit of the study treatment.

Exclusion Criteria:

  • Patients with AUR history
  • Patients with PSA ≥ 10 ng/ml or suspected prostate cancer
  • Patients who have an average total daily urine volume ≥ 3000 mL
  • Patients with suspected stress incontinence
  • Patients with PVR ≥200 ml or Qmax ≤5ml/sec

  • Patients who have used according to the criteria below:

    • Patients who began or discontinued the drug(s) or changed the dose within 4 weeks before enrollment
    • Patients who were treated with an anticholinergic agent, 5-aplha reductase inhibitor within 4 weeks before enrollment
    • Patients who began or discontinued 5ARI treatment or changed the dose within 6 months
  • Patients began or has changed a bladder training program or pelvic floor exercises less than 4 weeks prior to Screening.
  • Patients who had an indwelling catheter or practices intermittent self-catheterization
  • Patients who received surgical treatment that may influence urinary track function (TURP, laser therapy, etc.) within 24 weeks of run-in period
  • Uncontrolled hypertension: SBP ≥180 mmHg, DBP ≥110 mmHg
  • Pulse rate ≥110 bmp or <50 bpm
  • Patients with complications of urinary tract infection, urolithiasis and interstitial cystitis or past history of recurrent urinary tract infection
  • Patients with hypersensitivity to β-adrenergic receptor agonists or anticholinergics
  • Patients has a clinically significant ECG abnormality, as determined by the Investigator

Sites / Locations

  • Soon Chun Hyang University Hospital BucheonRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Korea University Ansan HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Kyung kook University HospitalRecruiting
  • Eulji University HospitalRecruiting
  • Ga-cheon University Gil HospitalRecruiting
  • Cheonnam University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Kang book Samsung HospitalRecruiting
  • Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

mirabegron

Arm Description

mirabegron placebo qd

mirabegron 50mg qd

Outcomes

Primary Outcome Measures

Change in mean number of micturitions per 24 hours

Secondary Outcome Measures

Change in mean number of urgency episodes per 24 hours
Change in mean number of urgency incontinence episodes per 24 hours
Change in a total of OABSS
Change in residual volume and maximal urinary flow rate
Change in IPSS storage subscore
Change in IPSS-QOL symptom score
Number of Adverse Events of study drug

Full Information

First Posted
December 11, 2014
Last Updated
February 6, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02361502
Brief Title
MIrabegron With oveRACtive bLadder Symptoms in mEn
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Comparison Clinical Study to Investigate the Efficacy and Safety of the β3 Adrenoceptor Agonist, Mirabegron With Overactive Bladder Symptoms in Men
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
The proportion of male patients who participated in the phase III study of mirabegron was about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients have limits. For this reason, this study will assess the efficacy and safety of mirabegron in Korean male OAB patients.
Detailed Description
About 50 to 75% of men with LUTS secondary to BPH also have overactive bladder symptoms. As a major drug for the treatment of overactive bladder symptoms, muscarinic receptor antagonists are used, but precautions should be taken by a specialist when using muscarinic receptor antagonists due to possibilities of dry mouth, constipation, blurred vision and post-dose dysuria and acute ischuria. Mirabegron is a selective β3-adrenoceptor agonist that relax the detrusor smooth muscle and increase functional bladder capacity to improve overactive bladder symptoms. This study will examine the efficacy and safety of mirabegron, a new drug, for improvement of urinary frequency. The efficacy of mirabegron compared to the placebo has been demonstrated by the phase III study, but the analysis of only patients in Korea has not obtained significant difference from the placebo. The prevalence of overactive bladder was 9.7% in men and 11.6% in women, which showed similar rates 1), but the cure rate is higher in men than in women (OR 1.891, CI 1.362, 2.2627, p=0.0001). Male patients are important customers for the OAB market and low-dose anticholinergic agents with relatively low risk of urinary retention are preferred for the treatment of male overactive bladder (OAB) in Korea. We will conduct this clinical study because we think mirabegron will be an alternative for the therapy for male OAB patients with a risk of urinary retention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
mirabegron placebo qd
Arm Title
mirabegron
Arm Type
Experimental
Arm Description
mirabegron 50mg qd
Intervention Type
Drug
Intervention Name(s)
mirabegron
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in mean number of micturitions per 24 hours
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in mean number of urgency episodes per 24 hours
Time Frame
after 12 weeks of treatment
Title
Change in mean number of urgency incontinence episodes per 24 hours
Time Frame
after 12 weeks of treatment
Title
Change in a total of OABSS
Time Frame
after 12 weeks of treatment
Title
Change in residual volume and maximal urinary flow rate
Time Frame
after 12 weeks of treatment
Title
Change in IPSS storage subscore
Time Frame
after 12 weeks of treatment
Title
Change in IPSS-QOL symptom score
Time Frame
after 12 weeks of treatment
Title
Number of Adverse Events of study drug
Time Frame
after 12 and 24 weeks of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male aged 20 years Patients with an average of at least 8 micturitions per 24 hours in last 3 days based on the micturition diary Patients with an average of at least 1 episode of urgency per 24 hours in last 3 days based on the micturition diary Patients who have symptoms of OAB for at least 12 weeks prior to the enrollment Patients who are able to complete the micturition diary and questionnaires correctly Patients who provided a singed consent form after being informed of the nature of the study and risk and benefit of the study treatment. Exclusion Criteria: Patients with AUR history Patients with PSA ≥ 10 ng/ml or suspected prostate cancer Patients who have an average total daily urine volume ≥ 3000 mL Patients with suspected stress incontinence Patients with PVR ≥200 ml or Qmax ≤5ml/sec Patients who have used according to the criteria below: Patients who began or discontinued the drug(s) or changed the dose within 4 weeks before enrollment Patients who were treated with an anticholinergic agent, 5-aplha reductase inhibitor within 4 weeks before enrollment Patients who began or discontinued 5ARI treatment or changed the dose within 6 months Patients began or has changed a bladder training program or pelvic floor exercises less than 4 weeks prior to Screening. Patients who had an indwelling catheter or practices intermittent self-catheterization Patients who received surgical treatment that may influence urinary track function (TURP, laser therapy, etc.) within 24 weeks of run-in period Uncontrolled hypertension: SBP ≥180 mmHg, DBP ≥110 mmHg Pulse rate ≥110 bmp or <50 bpm Patients with complications of urinary tract infection, urolithiasis and interstitial cystitis or past history of recurrent urinary tract infection Patients with hypersensitivity to β-adrenergic receptor agonists or anticholinergics Patients has a clinically significant ECG abnormality, as determined by the Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Woong Kim, M.D., Ph.D.
Phone
+82-2-2072-2426
Email
swkim@snu.ac.kr
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Ho Kim
Phone
82-10-2975-3262
Email
yhkuro@schmc.ac.kr
First Name & Middle Initial & Last Name & Degree
Young-Ho Kim, Ph.D.
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Jin Jeong, MD
Email
urojsj@snubh.org
First Name & Middle Initial & Last Name & Degree
Seong-Jin Jeong, MD
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hyun Bae, MD
First Name & Middle Initial & Last Name & Degree
Jae Hyun Bae, MD
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Gil Shin, Ph.D.
Phone
82-51-240-7351
Email
shindong16@hanmail.net
First Name & Middle Initial & Last Name & Degree
Dong Gil Shin, Ph.D.
Facility Name
Kyung kook University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Sang Yoo, MD
Email
uroyoo@knu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eun Sang Yoo, MD
Facility Name
Eulji University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hyo Woo, MD, PH D
Email
woosing@eulji.ac.kr
First Name & Middle Initial & Last Name & Degree
Seung Hyo Woo, MD, PH D
Facility Name
Ga-cheon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang jin yoon, MD
First Name & Middle Initial & Last Name & Degree
Sang jin yoon, MD
Facility Name
Cheonnam University Hospital
City
Kwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Wook Kang, MD, PH D
Email
sydad@hanmail.net
First Name & Middle Initial & Last Name & Degree
Tae Wook Kang, MD, PH D
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Woong Kim, M.D., Ph.D.
Phone
+82-2-2072-2426
Email
swkim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Soo Woong Kim, M.D.,Ph.D.
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Gab Jeong, MD, PhD
Email
igjeong@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
In Gab Jeong, MD, PhD
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Su Cho, MD
Email
kscho99@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Kang Su Cho, MD
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Goo Lee, MD
Email
uroyglee@nate.com
First Name & Middle Initial & Last Name & Degree
Young-Goo Lee, MD
Facility Name
Kang book Samsung Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwan joong Joo, MD, PhD
Email
urojoo@dreamwiz.com
First Name & Middle Initial & Last Name & Degree
Kwan joong Joo, MD, PhD
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang jin yoon, MD
First Name & Middle Initial & Last Name & Degree
Sang jin yoon, MD
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hwan Cheol Son, MD
First Name & Middle Initial & Last Name & Degree
Hwan Cheol Son, MD

12. IPD Sharing Statement

Learn more about this trial

MIrabegron With oveRACtive bLadder Symptoms in mEn

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