UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037233 |
|---|---|
| Receipt number | R000042453 |
| Scientific Title | Effectiveness and Safety of Vibegron in Patients with Overactive Bladder: A Retrospective Chart Review of Patient Outcomes |
| Date of disclosure of the study information | 2019/07/02 |
| Last modified on | 2019/11/28 17:08:41 |
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Basic information
Public title
Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Acronym
Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Scientific Title
Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Scientific Title:Acronym
Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of vibegron in patients with overactive bladder (OAB) under the real-world clinical setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in Overactive Bladder Symptom Score (OABSS) total score from baseline to 4 weeks
Key secondary outcomes
1) Change in OABSS sub-scores (4 elements) from baseline
2) Change in International Prostate Symptom Score (IPSS) total score from baseline
3) Change in IPSS sub-scores (3 and 7 elements) from baseline
4) Change in IPSS-QOL score from baseline
5) Proportion of subjects with minimum changes in OABSS total score
6) Individual scores of King's Health Questionnaire (KHQ)
7) Subgroup analyses for OABSS, IPSS, IPSS-QOL, and KHQ
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years who met the all following criteria;
1) Patients who treated with vibegron over 4 weeks for OAB during November, 2018 to June, 2019.
2) Patients who collected OABSS at the start of vibegron and 4 weeks later.
Key exclusion criteria
Nothing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Nishino |
Organization
Nishino Clinic, Koseikai Medical Corp.
Division name
director
Zip code
504-0941
Address
1-55-2, Miicho, Kakamigahara-shi, Gifu-Ken, 504-0941, Japan
TEL
058-371-0500
nishinoclinic-gifu@peace.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Rirei |
| Middle name | |
| Last name | Araiya |
Organization
Mebix, Inc.
Division name
Clinical Research Division
Zip code
107-0052
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan
TEL
03-4362-4504
Homepage URL
vibegron-retro@mebix.co.jp
Sponsor or person
Institute
Nishino Clinic, Koseikai Medical Corp.
Institute
Department
Personal name
Funding Source
Organization
KISSEI 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)
IRB Contact (For public release)
Organization
Adachi Kyosai Hospital Institutional Review Board
Address
1-36-8, Yanagihara, Adachi Ku, Tokyo, 120-0022, Japan
Tel
03-3881-6116
hashimoto.emiko@e-smo.co.jp
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
医療法人好誠会西野クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
We have evaluated the effects of vibegron on OAB. A total of 100 patients who had been administered vibegron once a day for at least 4 weeks between November 2018 and June 2019 were analyzed. The primary endpoint for effectiveness was the change in OABSS between baseline and four weeks. Four weeks after treatment, total OABSS score was significantly improved. No new safety concerns were identified.
Results date posted
| 2019 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 26 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Chart Review
Management information
Registered date
| 2019 | Year | 07 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042453
