UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002126
Receipt number R000002595
Scientific Title Clinical effect of Eviprostat in patients with high levels of PSA
Date of disclosure of the study information 2009/06/26
Last modified on 2013/01/07 21:09:07

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Basic information

Public title

Clinical effect of Eviprostat in patients with high levels of PSA

Acronym

Clinical effect of Eviprostat in patients with high levels of PSA

Scientific Title

Clinical effect of Eviprostat in patients with high levels of PSA

Scientific Title:Acronym

Clinical effect of Eviprostat in patients with high levels of PSA

Region

Japan


Condition

Condition

patients with high levels of PSA

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Changes of inflammation in prostate, serum PSA levels and lower urinary tract symptoms by intake of Eviprostat will be examined in patients with high levels of PSA without prostate cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Histological changes of prostate inflammation in prostate biopsy will be examined between before and after the intake of Eviprostat for 12 months.
Inflammation is assessed across all scores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Three tablets of Eviprostat three times per day for 12 months

Interventions/Control_2

no medication

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

Key inclusion criteria

1. age >=40
2. Written informed consent
3. serum PSA levels >=4.0
4. Patients without prostate cancer
5. Patients with lower urinary tract symptoms

Key exclusion criteria

1) patients with prostate cancer
2) patients with previous operation on prostate
3) Subjects taking any anti-androgen drugs
4) patients with prostatitis
5) Subjects with active urinary infection
6) Subjects with urethral catheter
7) Subjects with irritation to Eviprostat
8) Severe renal dysfunction
9) Severe liver dysfunction
10) Other ineligible subjects

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Fukuhara

Organization

University of Tokyo Hospital

Division name

Department of Uology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Fukuhara

Organization

University of Tokyo Hospital

Division name

Department of Uology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Urology, University of Tokyo Hospita

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, University of Tokyo Hospital

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

2009 Year 06 Month 26 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

Completed

Date of protocol fixation

2009 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 01 Day

Last follow-up date

2012 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 06 Month 26 Day

Last modified on

2013 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002595


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name