UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024764 |
|---|---|
| Receipt number | R000028488 |
| Scientific Title | Evaluation of safety and efficacy of combine therapy of immunoglobulin and colchicine in Kawasaki disease. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/11/11 19:33:18 |
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Basic information
Public title
Evaluation of safety and efficacy of combine therapy of immunoglobulin and colchicine in Kawasaki disease.
Acronym
Colchicine study in Kawasaki disease
Scientific Title
Evaluation of safety and efficacy of combine therapy of immunoglobulin and colchicine in Kawasaki disease.
Scientific Title:Acronym
Colchicine study in Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of combine therapy immunoglobulin and colchicine in Kawasaki disease patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
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
Taking Colchicine
<5 years old of age 0.5mg/kg/day
=>5years old of age 1mg/kg/day
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
| 6 | months-old | <= |
Age-upper limit
| 84 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patient suffered from Kawasaki disease who satisfy the following conditions
1) There must be a father, the mother, or the substitute who can understand the sentence.
2) Japanese
Key exclusion criteria
We exclude patients who fulfill below conditions
1) Patients who had history of hyper reaction for colchicine.
2) Patients who participated in other clinical trial in these 12 weeks.
3) Patients who have history of obvious allergy for any drug and food.
4) renal insufficiency.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Aso |
Organization
St. Marianna University School of Medicine
Division name
Pediatrics
Zip code
Address
2-16-1 Sugao Miyamaeku, Kawasaki, Japan
TEL
044-977-8111
k2aso@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Aso |
Organization
St. Marianna University School of Medicine
Division name
Pediatrics
Zip code
Address
2-16-1 Sugao Miyamaeku, Kawasaki, Japan
TEL
044-977-8111
Homepage URL
k2aso@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School 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
| 2016 | Year | 12 | Month | 01 | 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
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028488
