UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009137 |
|---|---|
| Receipt number | R000010710 |
| Scientific Title | Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia |
| Date of disclosure of the study information | 2012/10/18 |
| Last modified on | 2016/12/14 16:22:29 |
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Basic information
Public title
Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia
Acronym
Blue-Note study
Scientific Title
Clinical study of Solifenacin and Imidafenacin in OAB patients with nocturia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Sadaaki Sakamoto |
Organization
Nakamura Hospital
Division name
Urology
Zip code
Address
8-24 Akiba-cho, Beppu-city, Oita 874-0937, Japan
TEL
0977-23-3121
info4@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadaaki Sakamoto |
Organization
Nakamura Hospital
Division name
Urology
Zip code
Address
8-24 Akiba-cho, Beppu-city, Oita 874-0937, Japan
TEL
0977-23-3121
Homepage URL
info4@cres-kyushu.or.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2012 | Year | 10 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
