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 |
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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
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
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
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
