UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027308 |
|---|---|
| Receipt number | 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 07:31:11 |
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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
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
skato@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Second division, depertment of internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031187
