UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006789
Receipt number R000008032
Scientific Title Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.
Date of disclosure of the study information 2011/11/29
Last modified on 2015/10/15 11:54:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Acronym

Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Scientific Title

Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Scientific Title:Acronym

Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Region

Japan


Condition

Condition

scabies

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To propose more effective and safer dosage by analyzing blood, skin, mites after fed and fasted administration of STROMECTOL in scabies patients.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To analyze ivermectin in blood after fed and fasted administration.

Key secondary outcomes

To analyze ivermectin in skin, mites after fed and fasted administration.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

First, 200 ug/kg ivermectin are administerd on fast. A week later, same doses of ivermectin are administerd on food .Observation is continued one week after second administration..

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who were diagnosed with scabies.
2)Patients who needed hospitalization by scabies or other disease.
3)Subjects who understood the requirements of the study and signed the informed consent forms.

Key exclusion criteria

1)Subjects who had in the past or currently have following diseases.
;hepatic diseases
;other diseases which doctor in attendance considered to influence in results of study, or be penalized by administration of ivermectin.
2)Subjects who consumed excessive amounts of coffee or beverage containing caffeine.(over eight cups a day)
3)Drug or alcohol abuser.
4)Illegal drug constant user.
5)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.
6)Subjects who participated in another clinical trials with an investigational agent within four weeks prior to commencement of this study.
7)Subjects who had history of
hypersensitivity to constituent of
STROMECTOL
8)Subjects who are judged as inadequate by doctor in attendance.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Komoda

Organization

Tokyo University of Science

Division name

Faculty of Pharmaceutical Sciences

Zip code


Address

2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan

TEL

04-7121-4134

Email

komo1207@rs.noda.tus.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayo Komoda

Organization

Tokyo University of Science

Division name

Faculty of Pharmaceutical Sciences

Zip code


Address

2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan

TEL

04-7121-4134

Homepage URL


Email

komo1207@rs.noda.tus.ac.jp


Sponsor or person

Institute

Laboratory of medical safety
management, 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


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

2011 Year 11 Month 29 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

2011 Year 04 Month 06 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 10 Month 15 Day


Other

Other related information



Management information

Registered date

2011 Year 11 Month 29 Day

Last modified on

2015 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008032


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name