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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009343
Receipt No. R000010969
Scientific Title Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.
Date of disclosure of the study information 2012/11/15
Last modified on 2016/04/29

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Basic information
Public title Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.
Acronym Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.
Scientific Title Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.
Scientific Title:Acronym Clinical study on drug interactions and dosage administration of therapeutic drugs for nontuberculous mycobacterium infection.
Region
Japan

Condition
Condition Pulmonary Mycobacterium avium complex disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate relationship between changes of serum and sputum level and efficacy and safety in therapeutic drugs for pulmonary Mycobacterium avium complex disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The serum and sputum level of therapeutic drugs and their metabolite for pulmonary Mycobacterium avium complex disease.
Clinical symptoms of subjects (cough, sputum and hemosputum etc.), chest radiographic findings, examination of sputum (smear and culture) and clinical laboratory test results.
Key secondary outcomes The ratio of urinary 6beta-hydroxycortisol/free cortisol.

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who were diagnosed with pulmonary Mycobacterium avium complex disease.
2) Patients who needed drug therapy for pulmonary Mycobacterium avium complex disease.
3) Subjects who understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria 1)Subjects whose PS(Performance Status)are over 7 accordance with the Ordinance of the Ministry of Health, Labour and Welfare.
2)Subjects who had in the past or currently have following diseases.
;hepatic or renal diseases
;other diseases which doctor in attendance considered to influence in results of study, or be penalized by administration of clarithromycin, rifampicin and ethambutol.
3)Subjects who consumed excessive amounts of coffee or beverage containing caffeine.(over eight cups a day)
4)Drug or alcohol abuser.
5)Illegal drug constant user.
6)Men and women who donated two hundred milliliter of blood within four weeks prior to commencement of this study, or men who donated four hundred milliliter of blood within twelve weeks prior to commencement of this study, and women who donated four hundred milliliter of blood within sixteen weeks prior to commencement of this study.
7)Subjects who participated in another clinical trials with an investigational agent within four weeks prior to commencement of this study.
8)Subjects who had history of hypersensitivity to constituent of RIFADIN CAPSULES, CLARITH TABLETS and ESANBUTOL TABLETS.
9)Subjects who are judged as inadequate by doctor in attendance.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Aoyama
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7124-1501
Email t-aoyama@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Aoyama
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7124-1501
Homepage URL
Email t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chemotherapy research institute,
Kaken hospital
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 化学療法研究所附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4728759/
Number of participants that the trial has enrolled
Results
Our study demonstrated consistently low levels of serum CAM due to RFP-mediated induction of CYP3A4 in pulmonary MAC disease patients treated with a standard combination of CAM and RFP.  These continuously low concentrations of CAM are suggested to be responsible for unsatisfactory clinical outcomes of this disease.
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
2012 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 20 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 04 Month 29 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information The serum and sputum level of therapeutic drugs and their metabolite for pulmonary Mycobacterium avium complex disease.

Management information
Registered date
2012 Year 11 Month 15 Day
Last modified on
2016 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010969

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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