UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008863 |
|---|---|
| Receipt number | R000010407 |
| Scientific Title | Evaluation of the usefulness of anti-cholinergic and B(Beta)3 agonist in patients with OAB. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2016/12/14 16:18:27 |
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Basic information
Public title
Evaluation of the usefulness of anti-cholinergic and B(Beta)3 agonist in patients with OAB.
Acronym
Search of the clinical efficacy and safety for the Overactive bladder patients Received by imidafenacin and mirabegron as Therapeutic agents
(SORT Study)
Scientific Title
Evaluation of the usefulness of anti-cholinergic and B(Beta)3 agonist in patients with OAB.
Scientific Title:Acronym
Search of the clinical efficacy and safety for the Overactive bladder patients Received by imidafenacin and mirabegron as Therapeutic agents
(SORT Study)
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the usefulness after 12 weeks treatment with Imidafenacin and Mirabegron in OAB patients.(Treatment 1)
For patients who are insufficient in 12 weeks, we switch the drug (Imidafenacin to Mirabegron is, Mirabegron to Imidafenacin is) and evaluate the usefulness after further 12 weeks treatment. (Treatment 2)
In addition, we explore the factors that affect their usefulness in each medical agent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of total OABSS score
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.
For patients who are insufficient in 12 weeks, Mirabegron 50mg will be orally administered once a day after breakfast for further 12 weeks.
Interventions/Control_2
Mirabegron 50mg will be orally administered once a day after breakfast for 12 weeks.
For patients who are insufficient in 12 weeks, Imidafenacin 0.1mg will be orally administered twice a day, once after breakfast and dinner for further 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
Female
Key inclusion criteria
Treatment 1
1)OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2)
2)Outpatients
3)20 years old or more patients
4)Postmenopausal women
5)Patients from whom we have received written consent.
Treatment 2
1)OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2)
2)Patients who are insufficient in 12 weeks (not improved 3 scores in OABSS total)
3)Patients from whom we have received consent
Key exclusion criteria
1)Patients who has contraindication of Imidafenacin
2)Patients who has contraindication of Mirabegron
3)Patients with urinary flow decreased
4)Patients with history of urinary retention
5)Patients with arrhythmia
6)Patients with hypokalemia
7)Patients with serious kidney dysfunction
8)Residual urine volume is more than 100mL
9)Patients with bladder cancer, urinary tract stones, symptomatic urinary tract infection, recurrent urinary tract infection and interstitial cystitis.
10)Patients with polyuria
11)Patients who have administered prohibited substances or done prohibited therapy within the 4 weeks before enrollment
12)Patients who have a urology or genital surgery within the 6 months before enrollment
13)Patients with history of resistance to anti-holinergic agents
14)Lower urinary tract symptoms aren't stable.
15)Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Takeda |
Organization
University of Yamanashi
Division name
Department of Urology, School of Medicine
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi, Japan
TEL
055-273-9643
info3@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Takeda |
Organization
University of Yamanashi
Division name
Department of Urology, School of Medicine
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi, Japan
TEL
055-273-9643
Homepage URL
info3@cres-kyushu.or.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
山梨大学病院（山梨県）、信州大学病院（長野県）、名古屋大学病院（愛知県）、国立長寿医療研究センター（愛知県）、日本大学病院（東京都）、札幌医科大学附属病院（北海道）、神田医新クリニック（東京都）、永弘クリニック（埼玉県）、中嶋内科泌尿器科医院（埼玉県）、夏目泌尿器科（愛知県）、高村メディカルクリニック（愛知県）、きぬうら整形外科泌尿器科（愛知県）、相川泌尿器科医院（千葉県）、信濃町診療所Clinica Medica（東京都）、東九州泌尿器科（大分県）、春日町くりクリニック（東京都）、佐井泌尿器科・皮フ科クリニック（愛知県）、高羽クリニック（岐阜県）、おおむらクリニック（岐阜県）、ゆばクリニック（愛知県）、大脇病院（東京都）、うめやま医院（群馬県）、さくまクリニック（東京都）、渡辺医院（長野県）、さがみ屋泌尿器科クリニック（長野県）、しもがき泌尿器科クリニック（大阪府）、田泌尿器科クリニック（大阪府）、泌尿器科くろだクリニック（大阪府）、泌尿器科中村クリニック（大阪府）、染矢クリニック（大阪府）、いしだクリニック（兵庫県）、いずみ泌尿器科（兵庫県）、いまにし泌尿器科（兵庫県）、まつむら泌尿器科（兵庫県）、岡クリニック（兵庫県）、福田泌尿器皮膚科医院（兵庫県）、川原 腎・泌尿器科クリニック（鹿児島県）、札幌円山腎・泌尿器科クリニック（北海道）、三樹会病院（北海道）、ていね泌尿器科（北海道）、泌尿器科さいとうクリニック（北海道）、飛田医院（京都府）、サイ皮膚泌尿器科（愛知県）、清水クリニック（東京都）、大久保クリニック（東京都）、秀クリニック（東京都）、甲斐クリニック（愛知県）、にしさか腎・泌尿器科クリニック（大阪府）、遠藤医院（静岡県）、べっぷ腎・泌尿器クリニック（静岡県）、さとう泌尿器科クリニック（長野県）、東クリニック（鹿児島県）、たまいクリニック（鹿児島県）、北島病院（高知県）、となみクリニック（京都府）、尾関皮膚泌尿器科医院（東京都）、藤原医院（京都府）、川原泌尿器科（鹿児島県）、都田泌尿器科医院（大阪府）、まきのせ泌尿器科（鹿児島県）、塩川内科・泌尿器科クリニック（東京都）、弓削医院（東京都）、なかむら泌尿器科（千葉県）、烏山肛門大腸泌尿器クリニック水本医院（東京都）、松下泌尿器科医院（兵庫県）、原田泌尿器科クリニック（兵庫県）、みどり泌尿器科皮フ科医院（千葉県）、後楽園駅前診療所（東京都）、すやま泌尿器科クリニック（福岡県）、小林クリニック（愛知県）、大星クリニック（東京都）、かわい泌尿器科クリニック（福岡県）、泌尿器科上田クリニック（京都府）、あん医院（滋賀県）、ジェイタワークリニック（東京都）、セントラルクリニック伊勢崎（群馬県）、弁財泌尿器科・内科クリニック（埼玉県）、加野病院（福岡県）、八木クリニック（鹿児島県）、岩澤クリニック（北海道）、ノガキクリニック（東京都）、薬園台さかいクリニック（千葉県）、いいやま診療所（長野県）、北野泌尿器科医院（広島県）、すみいクリニック（広島県）、あいおいクリニック（千葉県）、市川東病院（千葉県）、小西医院（滋賀県）、小野寺クリニック（東京都）、尾松医院（滋賀県）、ごんクリニック（静岡県）、北村医院（大阪府）、鈴木医院（京都府）、かげやま医院（静岡県）、長久保病院（東京都）、つじ泌尿器科クリニック（滋賀県）、斎藤労災病院（千葉県）、林泌尿器科クリニック（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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 | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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 | 09 | Month | 06 | 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=R000010407
