UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010744
Receipt number R000012556
Scientific Title Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.
Date of disclosure of the study information 2013/05/17
Last modified on 2016/04/29 15:35:51

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Basic information

Public title

Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.

Acronym

Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.

Scientific Title

Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.

Scientific Title:Acronym

Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.

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 concentration 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

Not applicable


Assessment

Primary outcomes

Serum and sputum concentration of therapeutic drugs and their metabolites 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 receiving drug therapy of pulmonary Mycobacterium avium complex disease more than three months.
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

50


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 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


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

2013 Year 05 Month 17 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

2013 Year 05 Month 16 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 17 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Serum and sputum concentration of therapeutic drugs and their metabolites for pulmonary Mycobacterium avium complex
disease.


Management information

Registered date

2013 Year 05 Month 16 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=R000012556


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name