UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009423 |
|---|---|
| Receipt number | R000011071 |
| Scientific Title | Evaluation of immunomodulatory effects of macrolide antibiotics |
| Date of disclosure of the study information | 2012/11/28 |
| Last modified on | 2012/11/28 18:15:15 |
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Basic information
Public title
Evaluation of immunomodulatory effects of macrolide antibiotics
Acronym
Evaluation of immunomodulatory effects of macrolide antibiotics
Scientific Title
Evaluation of immunomodulatory effects of macrolide antibiotics
Scientific Title:Acronym
Evaluation of immunomodulatory effects of macrolide antibiotics
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of immunomodulatory effects of macrolide antibiotics
Basic objectives2
Others
Basic objectives -Others
Evaluation of cell differentiation after taking macrolide antibiotics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cell differentiation
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
macrolide antibiotics
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
Healthy volunteer
Key exclusion criteria
(1) Those who have a past hisotry of hypersensitivity to macrolide antibiotics
(2) Those who take any medications
(3) The person under pregnancy or breast-feeding
(4) A person aged 20 and below
(5) Those who have symptoms of diarrhea and constipation
(6) Those who are not consulting the medical examination in one year before this clinical study registration
(7) Those who admitted electrocardiographic abnormality by the prior medical examination
(8) Those who have renal dysfunction(creatinine clearance is 30 or less mL/min)
(9) Those who have liver dysfunction by the prior medical examination (AST or ALT is 40 or more IU/l)
(10) Those who judged as unsuitable by a doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Betsuyaku |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine Department of Medicine
Zip code
Address
35 Shinanomachi Shinjyuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine Department of Medicine
Zip code
Address
35 Shinanomachi Shinjyuku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine Division of Pulmonary Medicine Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Division of Pulmonary Medicine Department of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 28 | 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
| 2012 | Year | 11 | Month | 28 | Day |
Last modified on
| 2012 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011071
