- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376698
Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease (DRC-04)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Hiroshima, Japan
- Hiroshima University Hospital
-
Kanagawa, Japan
- Kitasato University Hospital
-
Okinawa, Japan
- Urasoe Sogo Hospital
-
Tochigi, Japan
- Dokkyo Medical University Nikko Medical Center
-
Tokyo, Japan
- Showa University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The subjects in this trial must have all of the following criteria.
Patients with type 2 diabetes mellitus with coronary artery disease(*1) with increased inflammatory response(*2).
- 1:"Type 2 diabetes" mellitus is diagnosed by criteria according to The Japan Diabetes Society. "Coronary artery disease" is defined as having equal to or greater than 75% stenosis in coronary angiography, history of acute coronary syndrome, and history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
- 2:"Increased inflammatory response" is defined as follow; White blood cell levels at confirmation tests of eligibility is equal to or greater than 7000 /μL.
- Patients aged 20 years and older
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(*3), patients with consent of performing optimal contraception from starting study drug to 90 days from final taking.
- 3: Male subjects who had undergone a contraceptive surgery are defined as elapsing for at least one year after vasectomy and having a certification of no sperm at ejaculation.
- 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.
Exclusion Criteria:
The subjects who conflict with at least one of the following criteria are exclude from this trial.
- Patients with prior hypersensitivity to Colchicine.
- Patients with taking Colhicine presently or to 30 days before confirmation tests of eligibility.
- Patients with liver cirrhosis
- Patients with clinical cholestasis.
- Patients with decreasing renal function (eGFR < 30 mL/min/1.73m2) at confirmation tests of eligibility.
- Patients with active malignancy.
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
- Strong Inhibitor Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, Preparation including Cobicistat
- Moderate Inhibitor Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil 2. P-glycoprotein inhibitor Ciclosporin
- Patients taking Amiodarone or Quinidine.
- Patients with infectious or inflammatory disease at confirmation tests of eligibility.
- Current smoker
- 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.)
- Patients registered in other clinical trials presently or within 30 days before acquisition consent of this trial.
- Patients whom physician in charge considered inappropriate for the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
oral administration of Placebo once daily for 12 weeks
|
Active Comparator: Colchicine 0.5 mg
|
oral administration of Colchicine 0.5 mg once daily for 12 weeks
|
Active Comparator: Colchicine 0.25 mg
|
oral administration of Colchicine 0.25 mg once daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum high-sensitivity CRP (mg/dl)
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum high-sensitivity CRP (mg/dl)
Time Frame: 12 weeks
|
12 weeks
|
Change in Flow Mediated Dilatation (%)
Time Frame: 12 weeks
|
12 weeks
|
Change in adhesive ability of white blood cell (number/field of view)
Time Frame: 4 weeks
|
4 weeks
|
Change in time through the microchannel of white blood cell (sec)
Time Frame: 4 weeks
|
4 weeks
|
Change in plasma myeloperoxidase level (ng/ml)
Time Frame: 4 and 12 weeks
|
4 and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 12 weeks
|
12 weeks
|
|
Cardiovascular events
Time Frame: 12 weeks
|
death, myocardial infarction, stroke, hospitalization due to worsening heart failure, unstable angina
|
12 weeks
|
Side effect
Time Frame: 12 weeks
|
12 weeks
|
|
Diarrhea
Time Frame: 12 weeks
|
especially notable adverse event
|
12 weeks
|
Concentration of colhicine in plasma (ng/ml)
Time Frame: 12 weeks
|
feasible facility only
|
12 weeks
|
Concentration of colhicine in white blood cell (ng/1*10^9 cells)
Time Frame: 12 weeks
|
feasible facility only
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shinichiro Ueda, PhD, blessyou@med.u-ryukyu.ac.jp
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Signs and Symptoms, Digestive
- Diabetes Mellitus
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Diabetes Mellitus, Type 2
- Inflammation
- Diarrhea
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
Other Study ID Numbers
- 1195 (Other Grant/Funding Number: Dairy Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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