UMIN-CTR Clinical Trial

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
Email	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
Email	k2aso@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028488