UMIN-CTR Clinical Trial

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

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Changes on frequency of urination at night on patients' bladder diary

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

N-QOL Study Group

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）　　

Date of disclosure of the study information

2014

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective observational study

Registered date

2014

Year

01

Month

09

Day

Last modified on

2015

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014961