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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009999
Receipt No. R000011707
Scientific Title Clinical evaluation of add-on administration of flavoxate hydrochloride in nocturia patients resistant to an anticholinergic agent
Date of disclosure of the study information 2013/02/12
Last modified on 2014/08/08

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Basic information
Public title Clinical evaluation of add-on administration of flavoxate hydrochloride in nocturia patients resistant to an anticholinergic agent
Acronym Clinical evaluation of add-on administration of flavoxate hydrochloride in nocturia patients
Scientific Title Clinical evaluation of add-on administration of flavoxate hydrochloride in nocturia patients resistant to an anticholinergic agent
Scientific Title:Acronym Clinical evaluation of add-on administration of flavoxate hydrochloride in nocturia patients
Region
Japan

Condition
Condition nocturia
Classification by specialty
Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the effectiveness of administration of flavoxate hydrochloride in patients with nocturia who was not adequately relieved by an anticholinergic agent.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes nocturia, Hours of undisturbed sleep, side effect
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 flavoxate hydrochloride, 200 mg, one tablet, once a day before sleep
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 1. nocturia (more than two times)
2. anticholinergic agent administration more than 8 weeks
Key exclusion criteria 1. obvious polyuria patients
2. patients with cancer
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Saito
Organization University of the Ryukyus
Division name Department of Urology
Zip code
Address 207 Uehara, Nishihara, Okinawa
TEL 098-895-1186
Email ssaito@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Miyazato
Organization University of the Ryukyus
Division name Department of Urology
Zip code
Address 207 Uehara, Nishihara, Okinawa
TEL 098-895-1186
Homepage URL http://www.cc.u-ryukyu.ac.jp/~uro/
Email miyaz929@med.u-ryukyu.ac.jp

Sponsor
Institute Department of Urology, University of the Ryukyus
Institute
Department

Funding Source
Organization University of the Ryukyus
Organization
Division
Category of Funding 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
2013 Year 02 Month 12 Day

Related information
URL releasing protocol http://www.cc.u-ryukyu.ac.jp/~uro/
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
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 12 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 08 Day
Last modified on
2014 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011707

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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