UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009343 |
|---|---|
| Receipt number | 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 17:27:53 |
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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
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
t-aoyama@rs.noda.tus.ac.jp
Sponsor or person
Institute
Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010969
