UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000006789
Receipt No. 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

* 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Laboratory of medical safety
management, Tokyo University of Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008032


Contact us.