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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016185
Receipt No. R000018786
Scientific Title Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Date of disclosure of the study information 2015/01/13
Last modified on 2015/01/12

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Basic information
Public title Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Acronym Low dose colchicine and endothelial function
Scientific Title Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Scientific Title:Acronym Low dose colchicine and endothelial function
Region
Japan

Condition
Condition Patients with stable coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of our study is a translational research of colchicine, which already has long history as an anti-gout drug, for the development as an anti-atherosclerotic drug. The present study will examine effects of multiple dose (7 days) of colchicine on endothelial function in patients with coronary artery diseases in a cross over design as a pilot study for pre-phase III study evaluating effects of colchicine on endothelial function in RCT under the ICH-GCP.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Endothelial function measured by FMD.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Colchicine at 0.5mg per day for 1 week
Interventions/Control_2 Placebo
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with coronary artery disease with condition being stable for previous 6 months.
2) Aged 20 years and over and less than 70 years old
3) Patients who voluntarily give informed consent after full explanation of the study

Coronary artery disease is defined as 1)significant stenosis (>AHA 75% ) of coronary arteries by CAG or coronary artery CT 2) history of PCI or CABG 3) history of acute coronary syndrome
Key exclusion criteria 1) Patients aged 70 and over and less than 20 years old
2) Patients receiving drugs interacting with colchicine through CYP3A4 and p-glycoprotein listed in the label.
3) Patients with impaired renal function being eGFR less than 30ml/min/1.73m2
4) Patients with liver cirrhosis
5) Patients with cholestasis
6) Patients with active malignant tumor
7) Patients who are expected mothers or on breast feeding.
8) Inappropriate patients for this study judged by doctors in charge.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Ueda
Organization University of the Ryukyus
Division name Department of Clinical Pharmacology & Therapeutics
Zip code
Address 207 Uehara, Nishiharacho, Okinawa, Japan
TEL 0988951195
Email blessyou@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Ueda
Organization University of the Ryukyus
Division name Department of Clinical Pharmacology & Therapeutics
Zip code
Address 207 Uehara, Nishiharacho, Okinawa, Japan
TEL 0988951195
Homepage URL
Email blessyou@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

Funding Source
Organization Grant-in-aid for scientific research from Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokyo Medical University, HIroshima University
Name of secondary funder(s) N/A

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 琉球大学(沖縄県),東京医科大学(東京都)、広島大学(広島県)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 13 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 Preinitiation
Date of protocol fixation
2014 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 15 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 11 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 12 Day
Last modified on
2015 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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