UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029170 |
|---|---|
| Receipt number | 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 | 2022/05/26 09:20:45 |
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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
54
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
blessyou@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | IKEHARA |
Organization
University of the Ryukyus Hospital
Division name
Clinical Research and Quality Management Center
Zip code
903-0125
Address
207 Uebaru,Nishihara-cho,Nakagami-gun,Okinawa
TEL
098-895-1509
Homepage URL
yikehara@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Graduate School of Medicine
Clinical Pharmacology and Therapeutics
Institute
Department
Personal name
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
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）、佐賀大学医学部附属病院(佐賀県)
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 01 | Day |
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
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033349
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