MIrabegron With oveRACtive bLadder Symptoms in mEn

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361502
• Other study ID #: MIRACLE
• Status: Recruiting
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: February 6, 2015
• Start date: February 2015

Study information

• Verified date: February 2015
• Source: Seoul National University Hospital
• Contact: Soo Woong Kim, M.D., Ph.D.
• Phone: +82-2-2072-2426
• Email: swkim[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 462
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 ß-adrenergic receptor agonists or anticholinergics

• Patients has a clinically significant ECG abnormality, as determined by the Investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• mirabegron

• placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyung kook University Hospital	Daegu
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Ga-cheon University Gil Hospital	Incheon
Korea, Republic of	Cheonnam University Hospital	Kwangju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Kang book Samsung Hospital	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean number of micturitions per 24 hours		after 12 weeks of treatment	No
Secondary	Change in mean number of urgency episodes per 24 hours		after 12 weeks of treatment	No
Secondary	Change in mean number of urgency incontinence episodes per 24 hours		after 12 weeks of treatment	No
Secondary	Change in a total of OABSS		after 12 weeks of treatment	No
Secondary	Change in residual volume and maximal urinary flow rate		after 12 weeks of treatment	Yes
Secondary	Change in IPSS storage subscore		after 12 weeks of treatment	No
Secondary	Change in IPSS-QOL symptom score		after 12 weeks of treatment	No
Secondary	Number of Adverse Events of study drug		after 12 and 24 weeks of treatment	Yes