UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004125
Receipt number R000004824
Scientific Title Treatment of tropical and parasitic diseases using medicines that are not licensed in Japan
Date of disclosure of the study information 2010/09/01
Last modified on 2021/03/11 15:32:45

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Basic information

Public title

Treatment of tropical and parasitic diseases using medicines that are not licensed in Japan

Acronym

Treatment of tropical and parasitic diseases using medicines that are not licensed in Japan

Scientific Title

Treatment of tropical and parasitic diseases using medicines that are not licensed in Japan

Scientific Title:Acronym

Treatment of tropical and parasitic diseases using medicines that are not licensed in Japan

Region

Japan


Condition

Condition

Tropical diseases, parasitic diseases

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the efficacy and safety of unlicensed medicines (19 items) that our research group introduced when they are administered to patients with tropical and parasitic diseases in Japan

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Clinical effects and adverse events due to drug treatments

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

When considered to be most appropriate, we administer unlicensed medicines (19 items) that our research group introduced to patients with tropical and parasitic diseases with the world-standard dosages and for the terms.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with tropical and parasitic diseases for whom treatment with unlicensed medicines that our research group introduced is considered to be most appropriate

Key exclusion criteria

Patients who are allergic to the drugs, patients for whom the possible disadvantages due to the drug adverse events may overweigh the advantages due to the drug's clinical effects

Target sample size

750


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Maruyama

Organization

University of Miyazaki, Faculty of Medicine

Division name

Department of Infectious Diseases

Zip code


Address

Kihara 5200, Kiyotake, Miyazaki 889-1692, Miyazaki, Japan

TEL

0985-85-0990

Email

hikomaru@med.miyazaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhiko Maruyama

Organization

University of Miyazaki, Faculty of Medicine

Division name

Department of Infectious Diseases

Zip code


Address

Kihara 5200, Kiyotake, Miyazaki 889-1692, Miyazaki, Japan

TEL

0985-85-0990

Homepage URL

http://trop-parasit.jp/

Email

hikomaru@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki, Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Government offices of other countries

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

宮崎大学医学部附属病院(宮崎県)、国立国際医療研究センター(東京都)、東京大学医科学研究所附属病院(東京都)を含む計医療31機関


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 01 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

2010 Year 08 Month 01 Day

Date of IRB

2011 Year 10 Month 27 Day

Anticipated trial start date

2011 Year 10 Month 27 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry

2017 Year 08 Month 31 Day

Date trial data considered complete

2017 Year 08 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

Shimizu S, Kikuchi T, Koga M, Kato Y, Matsuoka H, Maruyama H, Kimura M; Research Group on Chemotherapy of Tropical Diseases. Optimal primaquine use for radical cure of Plasmodium vivax and Plasmodium ovale malaria in Japanese travelers--A retrospective analysis. Travel Med Infect Dis. 2015 May-Jun;13(3):235-40. doi: 10.1016/j.tmaid.2014.11.005


Management information

Registered date

2010 Year 08 Month 30 Day

Last modified on

2021 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004824


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name