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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012804
Receipt No. R000014961
Scientific Title Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia
Date of disclosure of the study information 2014/01/10
Last modified on 2015/09/25

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Basic information
Public title Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia
Acronym Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia (METEOR STUDY)
Scientific Title Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia
Scientific Title:Acronym Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia (METEOR STUDY)
Region
Japan

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of mirabegron on female OAB patients who urinate twice or more during nighttime:
-how mirabegron would reduce the frequency of nocturnal urination
-how mirabegron would change patients' QOL by improving frequent micturition at night
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes on frequency of urination at night on patients' bladder diary
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria At a tentative enrollment: obtained informed consent from a patient)
(1) Female
(2) 50 years of age or older
(3) Don't wish to get pregnant
(4) On OABSS*1, the both scores of Q2 (nocturia) and Q3 (sudden urge to urinate) are more than 2 points, respectively
(5) Outpatients
(6) Pathients who can answer to questionnaires, go to a bathroom/restroom and measure their urine volume by themselves
(7) Patients who consent to study participation in writing

(At an official enrollment: start prescription of mirabegron)
(1) Urinate twice or more during nighttime, judging from patients' bladder diary
(2) On OABSS, the score of Q3 and the total score are more than 2, more than 4, respectively
*1: Overactive Bladder Symptom Score
Key exclusion criteria (1) Patients with a history of hypersensitivity to mirabegron
(2) Patients with a severe heart disease
[Mirabegron might worsen the heart disease since some adverse reactions such as heart rate elevation by mirabegron have been reported]
(3) Patients on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride
(4) Patients with long QT syndrome
(5) Patients prone to occur arrhythmia such as severe bradycardia or acute myocardial ischemia
(6) Patients who were taking anticholinergic drugs to treat OAB less than 3 months before study participation
(7) Patients with hypokalemia
(8) Patients with difficult-to-control hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, in a seated position)
(9) Patients with severe liver dysfunction
(10) Patients with renal failure
(11) Patients with glaucoma
(12) Patients with urination difficulty
(13) Patients with anuresis
(14) Patients whose residual urinary volume during the observational period is more than 100 mL
(15) Patients under treatment with placement of catheter or intermittent self-catheterization
(16) Patients whose urinary volume is more than 40mL/kg a day on average
(17) Patients complicated with urinary infection, urinary lithiasis or interstitial cystitis
(18) Patients complicated with bladder tumor
(19) Patients undergone surgical operation that might affect their urinary function within 6 months prior to study participation
(20) Patients who received non-drug therapy such as electrical stimulation (low-frequency therapy and magnetic stimulation, for example), biofeedback procedure, bladder training or pelvic floor muscle exercise within 6 months prior to initiation of the observational period
(21) Patients complied with/or with a history of mood disorder, psychoneurotic disorder or schizophrenia
(22) Patients considered as ineligible for this study by the investigator for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Momokazu Goto 1),Masaki Yoshida 2)
Organization 1) Nagoya University Graduate School of Medicine
2) National Center for Geriatrics and Gerontology
Division name 1) Department of Urology
Zip code
Address Office:
TEL 052-744-2985
Email gotoh@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Momokazu Goto
Organization Nagoya University
Division name Department of Urology, Nagoya University Graduate School of Medicine
Zip code
Address Office:
TEL 052-744-2985
Homepage URL
Email gotoh@med.nagoya-u.ac.jp

Sponsor
Institute N-QOL Study Group
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学附属病院(愛知県)       
独立行政法人 国立長寿医療研究センター(愛知県) 
日本赤十字社 名古屋第一赤十字病院(愛知県) 
かげやま医院(静岡県)           
名鉄病院(愛知県)          
社会保険 中京病院(愛知県)     
独立行政法人 国立病院機構 名古屋医療センター(愛知県) 
中部ろうさい病院(愛知県)    
刈谷豊田総合病院(愛知県)     
千田クリニック(愛知県)      
甲斐クリニック(愛知県)       
成田クリニック(愛知県)          
サイ皮膚泌尿器科(愛知県)        
佐井泌尿器・皮膚科クリニック(愛知県)    
高村メディカルクリニック(愛知県)      
にしくまもと病院(愛知県)  

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 25 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2014 Year 01 Month 09 Day
Last modified on
2015 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014961

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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