MIrabegron With oveRACtive bLadder Symptoms in mEn
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
1 other identifier
interventional
462
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFebruary 11, 2015
February 1, 2015
11 months
December 11, 2014
February 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mean number of micturitions per 24 hours
after 12 weeks of treatment
Secondary Outcomes (7)
Change in mean number of urgency episodes per 24 hours
after 12 weeks of treatment
Change in mean number of urgency incontinence episodes per 24 hours
after 12 weeks of treatment
Change in a total of OABSS
after 12 weeks of treatment
Change in residual volume and maximal urinary flow rate
after 12 weeks of treatment
Change in IPSS storage subscore
after 12 weeks of treatment
- +2 more secondary outcomes
Study Arms (2)
placebo
PLACEBO COMPARATORmirabegron placebo qd
mirabegron
EXPERIMENTALmirabegron 50mg qd
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Korea University Ansan Hospital
Ansan, South Korea
Pusan National University Hospital
Busan, South Korea
Kyung kook University Hospital
Daegu, South Korea
Eulji University Hospital
Daejeon, South Korea
Ga-cheon University Gil Hospital
Incheon, South Korea
Cheonnam University Hospital
Kwangju, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Kang book Samsung Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Seoul National University Hospital
Study Record Dates
First Submitted
December 11, 2014
First Posted
February 11, 2015
Study Start
February 1, 2015
Primary Completion
January 1, 2016
Last Updated
February 11, 2015
Record last verified: 2015-02