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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004341
Receipt No. R000005197
Scientific Title The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Date of disclosure of the study information 2010/11/01
Last modified on 2013/11/06

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Basic information
Public title The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Acronym The investigation on the effect of nocturia on sleep and the evaluation of efficacy of Imidafenacin.
Scientific Title The epidemiological investigation on the effect of nocturia on sleep and the evaluation of the interventional efficacy of Imidafenacin.
Scientific Title:Acronym The investigation on the effect of nocturia on sleep and the evaluation of efficacy of Imidafenacin.
Region
Japan

Condition
Condition Nocturia, Overactive bladder, Sleep disorder
Classification by specialty
Psychiatry Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of nocturia and sleep disorder on QOLs, using the questionnaire to patients. In addition, we evaluate the efficacy of an anti- cholinergic drug, Imidafenacin, on nocturia, sleep disorder, daytime sleepiness and QOLs for OAB patients with nocturia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The effect of nocturia and sleep disorder on QOLs
-Nocturia micturitions in the item of the overactive bladder symptom score ( OABSS )
-Pittsburgh sleep quality index ( PSQI )
-Epworth sleepiness scale ( ESS )
-8-Item short-form health survey
( SF-8 )
Key secondary outcomes 1.The frequency of OAB with nocturia and its effect on QOLs
-OABSS
-International prostate symptom score (IPSS)
-ESS
-SF-8
2.The interventinal efficacy of
Imidafenacin to patients with OAB
-The time course of global score, nocturia micturitions, sub-scores in OABSS.
-The time course of scores in PSQI, ESS and SF-8
3.The frequency of SAS with sleep disorder and its effect on QOLs
-The time course of nocturia micturitions in OABSS.
-ESS
-PSQI(Q10a and Q10b)
-SF-8

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Screening patients with nocturia more than once per night using overactive bladder symptom score ( OABSS ), the questionnaire to patients, consist of PSQI, ESS, SF-8 and IPSS, will be carried out.
Screening patients with overactive bladder using OABSS, eligible patients will receive 0.2-0.4 mg/day Imidafenacin for 12 weeks.
After 4 weeks of treatment with Imidafenacin, the efficacy of the treatment regimen will be assessed. If the effect of Imidafenacin is inadequate ( at least to sleep disturbance ), start internal use of sleeping pills ( 5 mg of Myslee ) with Imidafenacin. Patients administered already sleeping pills or resistant to new sleeping pills consider psychiatric consultation.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ( Intervention study )
The patients of overactive bladder with nocturia more than once per night.
Key exclusion criteria ( Intervention study )
The following patients must be excluded:
1) Patients with polyuria
2) Patients with post-void residual volume >100 cc.
3) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetaka Suekane
Organization Kurume University School of Medicine
Division name Department of Urology
Zip code
Address Asahi-machi 67, Kurume,
TEL 0942-31-7572
Email suekane@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name higetaka Suekane
Organization Kurume University School of Medicine
Division name Department of Urology
Zip code
Address Asahi-machi 67, Kurume,
TEL 0942-31-7572
Homepage URL
Email suekane@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Kurume University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 久留米大学病院(福岡県)、社会保険久留米第一病院(福岡県)、筑後市立病院(福岡県)、大牟田市立総合病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 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
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
2009 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 06 Day
Last modified on
2013 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005197

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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