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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024234
Receipt No. 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 2017/07/19

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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
Email 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
Email yokoso1046@shinshu-u.ac.jp

Sponsor
Institute Department of Urology, school of medicine, Shinshu university
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 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
2016 Year 09 Month 30 Day
Last modified on
2017 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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