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Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease

NCT03376698 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-05-12

No results posted yet for this study

Summary

This study is designed to investigate dose-dependent effects of low dose colchicine on inflammatory responses, endothelial function in type 2 diabetic patients with 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 , parallel group design. 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.

Conditions

Interventions

DRUG

Colchicine 0.5 mg

oral administration of Colchicine 0.5 mg once daily for 12 weeks

DRUG

Colchicine 0.25 mg

oral administration of Colchicine 0.25 mg once daily for 12 weeks

DRUG

Placebo

oral administration of Placebo once daily for 12 weeks

Sponsors & Collaborators

  • University of the Ryukyus

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2022-03-04
Completion
2022-04-01

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376698 on ClinicalTrials.gov