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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029170
Receipt No. R000033349
Scientific Title A randomized, double-blind, placebo-controlled phase II trial to evaluate the dose-dependent effect of colchicine on inflammatory response and endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation
Date of disclosure of the study information 2017/09/20
Last modified on 2019/05/08

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Basic information
Public title A randomized, double-blind, placebo-controlled phase II trial to evaluate the dose-dependent effect of colchicine on inflammatory response and endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation
Acronym Dose-finding study of colchicine in type 2 diabetic patients with coronary artery disease
Scientific Title A randomized, double-blind, placebo-controlled phase II trial to evaluate the dose-dependent effect of colchicine on inflammatory response and endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation
Scientific Title:Acronym Dose-finding study of colchicine in type 2 diabetic patients with coronary artery disease
Region
Japan

Condition
Condition type 2 diabetic patients with coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to investigate dose-dependent effects of low dose colchicine on inflammatory responses, endothelial function in type 2 diabetic patients coronary artery disease and leukocyte activation. This study also tested the relationship between doses and safety issue such as incidence of diarrhea. Eligible patients will be randomly allocated to three treatment group: colchicine at 0.5mg per day, 0.25mg per day or placebo for 12 weeks in a double blind , pararell group esign. High sensitive-CRP at 4 weeks as primary end point and flow mediated vasodilatation at 12 weeks as the secondary end point will be measured,
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes High sensitive-CRP at 4 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 colchicine 0.5mg
Interventions/Control_2 colchicine 0.25mg
Interventions/Control_3 placebo
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with type 2 diabetes mellitus with coronary artery disease with increased inflammatory response.
(2) Patients aged 20 years and older
(3) In female subjects who had possibility of pregnancy and male subjects who had female partner who had possibility of pregnancy and not undergone a contraceptive surgery, patients with consent of performing optimal contraception from starting study drug to 90 days from final taking.
(4) After receiving sufficient explanation for the participation of this study, patients who wrote document of informed consent by the patient's free will with sufficient understanding.
Key exclusion criteria (1)Patients with prior hypersensitivity to Colhicine.
(2)Patients with taking Colhicine presently or to 30 days before confirmation tests of eligibility.
(3)Patients with liver cirrhosis
(4)Patients with clinical cholestasis.
(5)Patients with decreasing renal function (eGFR < 30 mL/min/1.73m2) at confirmation tests of eligibility.
(6)Patients with active malignancy.
(7)Patients taking drugs that are indicated as "combined caution" in the package insert of Colchicine as a drug which may interact with Colchicine.
1. Drugs inhibiting cytochrome P450 drug-metabolizing enzyme
a. Strong Inhibitor
Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, Preparation including Cobicistat
b. Moderate Inhibitor
Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil
2. P-glycoprotein inhibitor
Ciclosporin
(8)Patients taking Amiodarone or Quinidine.
(9)Patients with infectious or inflammatory disease at confirmation tests of eligibility.
(10)Current smoker
(11)Patients with pregnancy, possible pregnancy, on breast-feeding or who wish to become pregnant during trial. (The female subjects who had possibility of pregnancy receive a pregnancy test.)
(12)Patients registered in other clinical trials presently or within 30 days before acquisition consent of this trial.
(13)Patients whom physician in charge considered inappropriate for the study.
Target sample size 69

Research contact person
Name of lead principal investigator
1st name SHINICHIRO
Middle name
Last name UEDA
Organization University of the Ryukyus
Division name Clinical Pharmacology and Therapeutics
Zip code 903-0125
Address 207 Uebaru,Nishihara-cho,Nakagami-gun,Okinawa
TEL 098-895-1195
Email blessyou@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name AKIHIRO
Middle name
Last name TOKUSHIGE
Organization University of the Ryukyus
Division name Clinical Pharmacology and Therapeutics
Zip code 903-0125
Address 207 Uebaru,Nishihara-cho,Nakagami-gun,Okinawa
TEL 098-895-1195
Homepage URL
Email akihiro@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Graduate School of Medicine
Clinical Pharmacology and Therapeutics
Institute
Department

Funding Source
Organization Japan Agency Medical Research and Development and Self-funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of the Ryukyus Hospital Institutional Review Board
Address 207 Uebaru,Nishihara-cho,Nakagami-gun,Okinawa
Tel 098-895-1351
Email rei-ryk@umin.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 1195
Org. issuing International ID_1 U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW 2017.07.28 1回

Institutions
Institutions 広島大学病院(広島県)、浦添総合病院(沖縄県)、北里大学病院(神奈川県)、獨協大学日光医療センター(栃木県)、昭和大学病院(東京都)、北光記念クリニック(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 16 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033349

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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