UMIN-CTR Clinical Trial

Public title

Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder.

Acronym

Efficacy and safety results from combination treatment with Imidafenacin and Mirabegron in patients with OAB (EstIMate Study).

Scientific Title

Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder.

Scientific Title:Acronym

Efficacy and safety results from combination treatment with Imidafenacin and Mirabegron in patients with OAB (EstIMate Study).

Region

Japan

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We evaluate the efficacy and safety after 12 weeks combination treatment of imidafenacin and mirabegron in patients with overactive bladder (OAB) who failed to improve nocturia after 4weeks treatment of 50mg/day of mirabegron.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of adverse drug reaction.
1) Incidence of QT prolongation (ECG findings: change of QT interval)
2) Incidence of other adverse drug reactions.

Key secondary outcomes

1) Baseline change of IPSS (International prostate symptom score) Q7 from 0week to 12 weeks.
2) Change of total OABSS (overactive bladder symptom score) and OABSS sub-score (diurnal frequency, nocturia, urinary urgency and impending incontinence).
3) Change of total IPSS score and IPSS sub-score (urination symptom, storage symptom).
4) Change of urination diary contents (the number of day urination, the number of night urination, the number of urinary urgency, the number of impending incontinence, dairy urination volume, night urination volume)
5) Change of first awakening time.
6) Change of residual urine volume.
7) Change of blood pressure and pulse.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Observation period:
Mirabegron 50mg will be orally administered once a day after breakfast 4 weeks.
Treatment period:
Mirabegron 50mg will be orally administered once a day after breakfast for 12 weeks.
Imidafenacin 0.1mg will be administered twice a day, once after breakfast and dinner for 12 weeks.

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

Male and Female

Key inclusion criteria

Start of observation period (-4 week)
1) OABSS Q2 (nocturia) score is more than 2.
2) OABSS Q3 (urgency) score is more than 2.
3) IPSS Q7 (nocturia) score is more than 2.
4) Postmenopausal women or men who do not hope for children.
5) 50 years old or more patients at enrollment.
6) Outpatients who are able to give informed consent.
7) Patients from whom we have received written consent.

Treatment period (at 0 week)
1) IPSS Q7 score is more than 1.

Key exclusion criteria

Start of observation period (-4wks)
1) Patients who has contraindication of imidafenacin
1. Patients with urinary retention.
2. Patients with pyloric stenosis, duodenal ileus, enterocleisis and patients with adynamic ileus.
3. Patients with deterioration of enterokinesis.
4. Patients with narrow-angle glaucoma.
5. Patients with myasthenia gravis.
6. Patients with serious cardiac disorder.
7. Patients with a history of hypersensitivity to imidafenacin.
2) Patients who has contraindication of mirabegron.
1. Patients with a history of hypersensitivity to mirabegron.
2. Patients with serious cardiac disorder.
3. Women who have pregnancy, possibility of the pregnancy.
4. Women who are nursing.
5. Patients with serious liver dysfunction (Child-Pugh score >=10).
6. Patients taking flecainide acetate or propafenone hydrochloride.
3) Patients with severe difficulty of urination.
4) Patients with history of urinary retention
5) Patients with arrhythmia.
6) Patients with hypokalemia.
7) Patients with serious kidney dysfunction.
8) Patients with bladder cancer, prostate cancer, stones in bladder, urinary tract stones, interstitial cystitis, prostatitis and symptomatic urinary tract infection.
9) Patients with genuine stress urinary incontinence.
10) Patients with polyuria.
11) Patients with severe hypertension (SBP >=180mmHg and/or DBP >=110mmHg under sitting position).
12) Patients who have administered prohibited substances or done prohibited therapy within 4 weeks before observation period.
13) Patients who have a urology or genital surgery within the 6 months before observation period.
14) Patients with unstable lower urinary tract symptoms.
15) Patients taking drugs that have possibility of QT prolongation.
16) Any other patients who are regarded as unsuitable for this study by the investigator

Treatment period (at 0 week):
1) Residual urine volume is more than 50 mL
2) Patients with QT interval >450ms or risk of QT prolongation.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kazuya Kawahara

Organization

Kawahara Clinic

Division name

Department of Urology

Zip code

Address

73-3 Nishimochida, Aira-city, Kagoshima 889-5431, Japan

TEL

099-564-5181

Email

kazi@kawahara.or.jp

Name of contact person

1st name
Middle name
Last name	Kazuya Kawahara

Organization

Kawahara Clinic

Division name

Department of Urology

Zip code

Address

73-3 Nishimochida, Aira-city, Kagoshima 889-5431, Japan

TEL

099-564-5181

Homepage URL

Email

kazi@kawahara.or.jp

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

川原腎・泌尿器科クリニック（鹿児島県）

Date of disclosure of the study information

2015

Year

01

Month

16

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

2014

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2016

Year

05

Month

20

Day

Date analysis concluded

2016

Year

07

Month

20

Day

Other related information

Registered date

2015

Year

01

Month

16

Day

Last modified on

2016

Year

09

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018843