Overactive BladderPhase 4NCT02361502
MIrabegron With oveRACtive bLadder Symptoms in mEn
A Phase 4 study testing mirabegron in people with Overactive Bladder, run by Seoul National University Hospital at 15 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Feb 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 17Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites, 15 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Jae Hyun Bae, MD
Jae Hyun Bae, MD
- Recruiting
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do
Young-Ho Kim, 82-10-2975-3262, yhkuro@schmc.ac.kr
Young-Ho Kim, Ph.D.
- Recruiting
Pusan National University Hospital
Busan
Dong Gil Shin, Ph.D., 82-51-240-7351, shindong16@hanmail.net
Dong Gil Shin, Ph.D.
- Recruiting
Kyung kook University Hospital
Daegu
Eun Sang Yoo, MD, uroyoo@knu.ac.kr
Eun Sang Yoo, MD
- Recruiting
Eulji University Hospital
Daejeon
Seung Hyo Woo, MD, PH D, woosing@eulji.ac.kr
Seung Hyo Woo, MD, PH D
- Recruiting
Ga-cheon University Gil Hospital
Incheon
Sang jin yoon, MD
Sang jin yoon, MD
- Recruiting
Cheonnam University Hospital
Kwangju
Tae Wook Kang, MD, PH D, sydad@hanmail.net
Tae Wook Kang, MD, PH D
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Seong-Jin Jeong, MD, urojsj@snubh.org
Seong-Jin Jeong, MD
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Soo Woong Kim, M.D., Ph.D., +82-2-2072-2426, swkim@snu.ac.kr
Soo Woong Kim, M.D.,Ph.D.
- Recruiting
Asan Medical Center
Seoul
In Gab Jeong, MD, PhD, igjeong@amc.seoul.kr
In Gab Jeong, MD, PhD
- Recruiting
Gangnam Severance Hospital
Seoul
Kang Su Cho, MD, kscho99@yuhs.ac
Kang Su Cho, MD
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul
Young-Goo Lee, MD, uroyglee@nate.com
Young-Goo Lee, MD
- Recruiting
Kang book Samsung Hospital
Seoul
Kwan joong Joo, MD, PhD, urojoo@dreamwiz.com
Kwan joong Joo, MD, PhD
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Sang jin yoon, MD
Sang jin yoon, MD
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Hwan Cheol Son, MD
Hwan Cheol Son, MD
About this study
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
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- mirabegron, placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | mirabegron placebo qd Receives: Drug: placebo |
| mirabegron | Experimental | mirabegron 50mg qd Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean number of micturitions per 24 hours
Measured: after 12 weeks of treatment
Secondary outcomes (7)
Change in mean number of urgency episodes per 24 hours
Measured: after 12 weeks of treatment
Change in mean number of urgency incontinence episodes per 24 hours
Measured: after 12 weeks of treatment
Change in a total of OABSS
Measured: after 12 weeks of treatment
Change in residual volume and maximal urinary flow rate
Measured: after 12 weeks of treatment
Change in IPSS storage subscore
Measured: after 12 weeks of treatment
Change in IPSS-QOL symptom score
Measured: after 12 weeks of treatment
Number of Adverse Events of study drug
Measured: after 12 and 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Woong Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361502
- Sponsor's protocol ID
- MIRACLE
- Status last verified
- Feb 2015
- First submitted
- 11 Dec 2014
- Last updated
- 11 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02361502
- Acronym / sponsor ID
- MIRACLE
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebomirabegron placebo qd |
| mirabegron | Experimental | Drug: mirabegronmirabegron 50mg qd |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegron | Drug | mirabegron |
| placebo | Drug | placebo |
Primary outcome
Change in mean number of micturitions per 24 hours
Time frame: after 12 weeks of treatment
7 secondary outcomes
Change in mean number of urgency episodes per 24 hours
Time frame: after 12 weeks of treatment
Change in mean number of urgency incontinence episodes per 24 hours
Time frame: after 12 weeks of treatment
Change in a total of OABSS
Time frame: after 12 weeks of treatment
Change in residual volume and maximal urinary flow rate
Time frame: after 12 weeks of treatment
Change in IPSS storage subscore
Time frame: after 12 weeks of treatment
Change in IPSS-QOL symptom score
Time frame: after 12 weeks of treatment
Number of Adverse Events of study drug
Time frame: after 12 and 24 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
Related trials for Overactive Bladder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirabegron in people with Overactive Bladder, run by Seoul National University Hospital at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Woong Kim, M.D., Ph.D. (+82-2-2072-2426, swkim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean number of micturitions per 24 hours (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.