UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018589
Receipt number R000018657
Scientific Title Japan PHarmacological Audit study of Safety and Efficacy in Realworld (Phase-R) Delirium Study
Date of disclosure of the study information 2015/08/10
Last modified on 2018/02/20 15:50:19

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Basic information

Public title

Japan PHarmacological Audit study of Safety and Efficacy in Realworld (Phase-R) Delirium Study

Acronym

Phase-R Delirium Study

Scientific Title

Japan PHarmacological Audit study of Safety and Efficacy in Realworld (Phase-R) Delirium Study

Scientific Title:Acronym

Phase-R Delirium Study

Region

Japan


Condition

Condition

Malignancy

Classification by specialty

Medicine in general Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of antipsychotic treatments for delirium in palliative care units and psychooncology consultation settings.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Delirium Rating Scale R-98 on day 3

Key secondary outcomes

NuDESC item 2-4
Communication Capacity Scale item 4
Agitation Distress Scale item 2
Adverse events
Drug-induced Extra-piramidal Symptom Scale(DIEPSS)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients with advanced cancer aged 18 years or older who undergo antipsychotic treatments for hyper- or hypoactive delirium in palliative care units or psycho-oncology consultation settings

Key exclusion criteria

Patients with substance withdrawal delirium
Patient with postoperative delirium
Patients who undergo medical treatments intended to terminal sedation

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Asao Ogawa

Organization

National Cancer Center East

Division name

Psycho-Oncology Division

Zip code


Address

6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Email

asogawa@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keisuke Ariyoshi

Organization

The University of Tokyo, The Institute of Medical Science

Division name

Department of Palliative Medicine

Zip code


Address

4-6-1 Shiroganedai, Minato-ku, Tokyo, Japan

TEL

03-3443-8111

Homepage URL

http://www.jortc.jp/

Email

k-ariyoshi@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo, The Institute of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

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

国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
名古屋市立大学大学院(愛知県)
岡山大学病院(岡山県)
千葉県がんセンター(千葉県)
市立札幌病院(北海道)
埼玉県立がんセンター(埼玉県)
東京大学医学部附属病院(東京都)
滋賀医科大学(滋賀県)
国立病院機構 近畿中央胸部疾患センター(大阪府)
慶應義塾大学病院(東京都)
聖隷三方原病院(静岡県)
小牧市民病院(岐阜県)
外旭川病院(秋田県)
川崎市立井田病院かわさき総合ケアセンター(神奈川県)
筑波メディカルセンター病院(茨城県)
ガラシア病院(大阪府)
聖路加国際病院(東京都)
栃木県立がんセンター(栃木県)
岡山済生会総合病院(岡山県)
六甲病院(兵庫県)
大阪市立総合医療センター(大阪府)
東北大学病院(宮城県)
島根大学医学部附属病院(島根県)
JCHO東京新宿メディカルセンター(東京都)
兵庫県立加古川医療センター(兵庫県)
永寿総合病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 10 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

2014 Year 01 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Safety (Day7) and efficacy (Day3) of antipsychotic treatments for hyper- and hypoactive delirium will be evaluated


Management information

Registered date

2015 Year 08 Month 07 Day

Last modified on

2018 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name