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


Email



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


Email



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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name