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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004125
Receipt No. 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 2017/11/21

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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
Institute University of Miyazaki, Faculty of Medicine
Institute
Department

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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.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


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