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MIrabegron With oveRACtive bLadder Symptoms in mEn

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ClinicalTrials.gov Identifier: NCT02361502
Recruitment Status : Unknown
Verified February 2015 by Soo Woong Kim, MD, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Soo Woong Kim, MD, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: mirabegron Drug: placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Placebo Comparator: placebo
mirabegron placebo qd
Drug: placebo
Experimental: mirabegron
mirabegron 50mg qd
Drug: mirabegron



Primary Outcome Measures :
  1. Change in mean number of micturitions per 24 hours [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Change in mean number of urgency episodes per 24 hours [ Time Frame: after 12 weeks of treatment ]
  2. Change in mean number of urgency incontinence episodes per 24 hours [ Time Frame: after 12 weeks of treatment ]
  3. Change in a total of OABSS [ Time Frame: after 12 weeks of treatment ]
  4. Change in residual volume and maximal urinary flow rate [ Time Frame: after 12 weeks of treatment ]
  5. Change in IPSS storage subscore [ Time Frame: after 12 weeks of treatment ]
  6. Change in IPSS-QOL symptom score [ Time Frame: after 12 weeks of treatment ]
  7. Number of Adverse Events of study drug [ Time Frame: after 12 and 24 weeks of treatment ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361502


Contacts
Contact: Soo Woong Kim, M.D., Ph.D. +82-2-2072-2426 swkim@snu.ac.kr

Locations
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Gyeonggi, Korea, Republic of
Contact: Young-Ho Kim    82-10-2975-3262    yhkuro@schmc.ac.kr   
Principal Investigator: Young-Ho Kim, Ph.D.         
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Contact: Seong-Jin Jeong, MD       urojsj@snubh.org   
Principal Investigator: Seong-Jin Jeong, MD         
Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of
Contact: Jae Hyun Bae, MD         
Principal Investigator: Jae Hyun Bae, MD         
Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Dong Gil Shin, Ph.D.    82-51-240-7351    shindong16@hanmail.net   
Principal Investigator: Dong Gil Shin, Ph.D.         
Kyung kook University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Eun Sang Yoo, MD       uroyoo@knu.ac.kr   
Principal Investigator: Eun Sang Yoo, MD         
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Seung Hyo Woo, MD, PH D       woosing@eulji.ac.kr   
Principal Investigator: Seung Hyo Woo, MD, PH D         
Ga-cheon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Contact: Sang jin yoon, MD         
Principal Investigator: Sang jin yoon, MD         
Cheonnam University Hospital Recruiting
Kwangju, Korea, Republic of
Contact: Tae Wook Kang, MD, PH D       sydad@hanmail.net   
Principal Investigator: Tae Wook Kang, MD, PH D         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Soo Woong Kim, M.D., Ph.D.    +82-2-2072-2426    swkim@snu.ac.kr   
Principal Investigator: Soo Woong Kim, M.D.,Ph.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: In Gab Jeong, MD, PhD       igjeong@amc.seoul.kr   
Principal Investigator: In Gab Jeong, MD, PhD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kang Su Cho, MD       kscho99@yuhs.ac   
Principal Investigator: Kang Su Cho, MD         
Hallym University Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young-Goo Lee, MD       uroyglee@nate.com   
Principal Investigator: Young-Goo Lee, MD         
Kang book Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kwan joong Joo, MD, PhD       urojoo@dreamwiz.com   
Principal Investigator: Kwan joong Joo, MD, PhD         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sang jin yoon, MD         
Principal Investigator: Sang jin yoon, MD         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hwan Cheol Son, MD         
Principal Investigator: Hwan Cheol Son, MD         
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Soo Woong Kim, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02361502     History of Changes
Other Study ID Numbers: MIRACLE
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents