UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024234 |
|---|---|
| Receipt number | R000027907 |
| Scientific Title | Nocturia QOL evaluation in OAB patients treated with Oxybutinin & Mirabegron study |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2023/10/17 18:49:34 |
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Basic information
Public title
Nocturia QOL evaluation in OAB patients treated with Oxybutinin & Mirabegron study
Acronym
NEOXY study
Scientific Title
Nocturia QOL evaluation in OAB patients treated with Oxybutinin & Mirabegron study
Scientific Title:Acronym
NEOXY study
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of oxybutynin tape for nocturia and sleep quality is evaluated in overactive bladder patients with nocturia, setting as a reference selective beta-3 adrenergic receptor agonist Mirabegron.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N-QOL 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
Arm of oxybutynin tape 73.5mg per one day for 8 weeks.
Interventions/Control_2
Arm of mirabegron 50mg per one day for 8 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
20 years of age or older of overactive bladder female patients with nocturia symptoms.
Key exclusion criteria
(1) Patients in the study drug administration proposed site with a skin disease and skin abnormalities.
(2) Patients with residual urine volume greater than 100mL.
(3) Patients with a difficulty in going to the bathroom without the assistance.
(4) Patients with a history of hypersensitivity of Oxybutynin hydrochloride or Mirabegron.
(5) Patients receiving flecainide acetate or propafenone hydrochloride.
(6) Patients with severe blood, liver, kidney disease and severe arrhythmia, suffering from cardiovascular diseases such as congestive heart failure.
(7) Patients with hypokalemia (less than 3.5mEq / L).
(8) Patients with paralytic ileus, ulcerative colitis, stomach atony, patients suffering from gastrointestinal diseases, such as bowel atony.
(9) Patients with Parkinson's syndrome, dementia, suffering from psychiatric and neurological disorders or cerebrovascular disorders such as myasthenia gravis.
(10) Patients with a glaucoma.
(11) Patients with a hyperthyroidism.
(12) Patients with malignant tumors.
(13) Pregnant patients, patients in lactating, and patients want to become pregnant during test period.
(14) Patients who participated in the other interventions tested within 16 weeks prior to study drug administration.
(15) Other, patient that investigators or test sharing doctor was ineligible as a subject of the present study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ishizuka |
Organization
Department of Urology, school of medicine, Shinshu university
Division name
Urology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
+81263-35-4600
yokoso1046@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Suzuki |
Organization
Department of Urology, school of medicine, Shinshu university
Division name
Urology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
+81263-35-4600
Homepage URL
yokoso1046@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Urology, school of medicine, Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Hisamitsu Pharmaceutical Co.,Inc
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
| 2016 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027907
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