UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder.
Title of the study (Brief title)	Efficacy and safety results from combination treatment with Imidafenacin and Mirabegron in patients with OAB (EstIMate Study).
Region	Japan

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

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kazuya Kawahara
Organization	Kawahara Clinic
Division name	Department of Urology
Address	73-3 Nishimochida, Aira-city, Kagoshima 889-5431, Japan
TEL	099-564-5181
Email	kazi@kawahara.or.jp

Public contact
Name of contact person	Kazuya Kawahara
Organization	Kawahara Clinic
Division name	Department of Urology
Address	73-3 Nishimochida, Aira-city, Kagoshima 889-5431, Japan
TEL	099-564-5181
Homepage URL
Email	kazi@kawahara.or.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Kyorin Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	川原腎・泌尿器科クリニック（鹿児島県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 16 Day
Last modified on	2016 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018843