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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027308
Receipt No. R000031187
Scientific Title CYP3A activity during nontuberculous mycobacterium infection
Date of disclosure of the study information 2017/05/15
Last modified on 2019/03/01

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Basic information
Public title CYP3A activity during nontuberculous mycobacterium infection
Acronym CYP3A activity during nontuberculous mycobacterium infection
Scientific Title CYP3A activity during nontuberculous mycobacterium infection
Scientific Title:Acronym CYP3A activity during nontuberculous mycobacterium infection
Region
Japan

Condition
Condition Nontuberculous Mycobacterial Lung Disease
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine CYP3A activity during nontuberculous mycobacterium infection.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CYP3A activity
Key secondary outcomes Pharmacokinetics, Safety

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 midazolam 1mg
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients aged 20 years or older who treat nontuberculous mycobacterium infection using rifampicin and clarithromycin.
2) Patients who do not have drug allergy or idiosyncrasy.
3) Patients who do not have a history of drug dependence, alcohol dependence, etc.
4) Patients who can obtain written consent.
Key exclusion criteria 1) The history of drug hypersensitivity.
2) The presence of severe renal or liver dysfunction.
3) Patients who are unable to continue taking medicine.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu university school of medicine
Division name Second division, depertment of internal medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan.
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Kato
Organization Hamamatsu university school of medicine
Division name Second division, depertment of internal medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL 053-435-2263
Homepage URL http://hamamatsu-lung.com/study.html
Email skato@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Second division, depertment of internal medicine
Institute
Department

Funding Source
Organization Hamamatsu university school of medicine
Second division, depertment of internal medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Respiratory meidicine, National hospital organization Tenryu hospital
Department of clinical pharmacology and therapeutics, Hamamatsu university school of medicine
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 浜松医科大学附属病院(静岡県),国立病院機構天竜病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 15 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
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 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
2017 Year 05 Month 11 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031187

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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