UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009999 |
|---|---|
| Receipt number | 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 15:00:06 |
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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
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/
miyaz929@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Department of Urology, University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011707
