UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013063
Receipt number R000015239
Scientific Title Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Date of disclosure of the study information 2014/02/07
Last modified on 2015/11/06 19:04:13

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Basic information

Public title

Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction

Acronym

Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction

Scientific Title

Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction

Scientific Title:Acronym

Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction

Region

Japan


Condition

Condition

patients with voiding dysfunction such as benign prostatic hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the efficacy of the drug of Parkinson`s disease on voiding dysfunction

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

voiding efficacy (Qmax)

Key secondary outcomes

urinary frequency
questionaires for urinary symptom


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

observation period: 4week
the drug of Parkinson`s disease is administered for 12 weeks
The outcomes is evaluated every 4 weeks

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

# international prostate symptom score (IPSS): >8
# QOL score: >4
# voided volume >100ml, Qmax: <15ml
# residual volume: <100ml
# eligible for coming to the outpatient clinic
# stable condition

Key exclusion criteria

# neurogenic bladder, bladder neck contracture, urethral stricture, urinary tract infection or other complication

# clear intermittent self catheterization
# allergic to the drug

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruyuki Ogawa

Organization

Shinshu University School of Medicine

Division name

Department of urology

Zip code


Address

3-1-1 Asahi Matsumoto Nagano, Japan

TEL

0263-37-2661

Email

ogawat@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teruyuki Ogawa

Organization

Shinshu University School of Medicine

Division name

Department of urology

Zip code


Address

3-1-1 Asahi Matsumoto Nagano, Japan

TEL

0263-37-2661

Homepage URL


Email

ogawat@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of drug discovery science, Shinshu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

2014 Year 02 Month 07 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

Terminated

Date of protocol fixation

2014 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 07 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

2014 Year 02 Month 03 Day

Last modified on

2015 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name