UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia
Title of the study (Brief title)	Blue-Note study
Region	Japan

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

Objectives
Narrative objectives1	We evaluate the clinical usefulness after 12 weeks treatment with Imidafenacin and solifenacin in OAB patients with nocturia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Usefulness for nocturia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Imidafenacin 0.1mg will be orally administered twice a day, once after breakfast and dinner for 12 weeks.
Interventions/Control_2	Solifenacin 5mg will be orally administered once after breakfast for 12 weeks.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2) 2) 20 years old or more patients 3) Patients from whom we have received written consent.
Key exclusion criteria	1) Patients who have administered prohibited substances or done prohibited therapy within the 4weeks before enrollment 2) Patients who started restricted substances and changed usage or dosage of restricted substances for determined period before enrollment 3) Patients with prostate cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stones and interstitial cystitis 4) Patients with urinary retention 5) Patients with obstruction of pylorus, duodenum and gut and patients with paralytic ileus 6) Patients with decrease of enterokinesis and gastrointestinal tract tension 7) Patients with closure-angle glaucoma 8) Patients with myasthenia gravis 9) Patients with serious liver dysfunction, kidney dysfunction and heart disease. 10) Hypersensitivity to anti-cholinergic agents. 11) Residual urine volume is more than 100mL 12) Patients with polyuria 13) Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size	80

Research contact person
Name of lead principal investigator	Sadaaki Sakamoto
Organization	Nakamura Hospital
Division name	Urology
Address	8-24 Akiba-cho, Beppu-city, Oita 874-0937, Japan
TEL	0977-23-3121
Email	info4@cres-kyushu.or.jp

Public contact
Name of contact person	Sadaaki Sakamoto
Organization	Nakamura Hospital
Division name	Urology
Address	8-24 Akiba-cho, Beppu-city, Oita 874-0937, Japan
TEL	0977-23-3121
Homepage URL
Email	info4@cres-kyushu.or.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
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	医療法人恵愛会　中村病院（大分県）、医療法人凛彩会　かさぎ泌尿器科医院（大分県）

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 16 Day
Anticipated trial start date	2012 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 10 Month 18 Day
Last modified on	2016 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010710