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

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 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


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

Value
https://center6.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