Phase
Condition
Thrombosis
Venous Thromboembolism
Vascular Diseases
Treatment
Colchicine 0.5 mg po
Placebo 0.5 mg po
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Consenting patients 18 years of age or older with a first, acute, symptomaticproximal (popliteal vein or more proximal) objectively confirmed DVT of the lowerextremity will be eligible to participate in the study.
Exclusion
Exclusion Criteria:
History of an allergic reaction or significant sensitivity to colchicine.
Requirement of colchicine for other indications.
Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn'sdisease or ulcerative colitis), collagenous colitis or irritable bowel syndrome orexisting blood dyscrasias.
Known or suspected, recent (<30 days) or active infections (acute or chronic).
History of cirrhosis, chronic active hepatitis, or severe liver disease.
Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressivedrugs (including but not limited to steroids, tumor necrosis factor-alpha blockers,cyclosporine).
Known active cancer.
Any of the following as measured within the past 1-3 months or at screening:alanine, or aspartate aminotransferase >3 times the upper limit of normal, totalbilirubin >2 times the upper limit of normal and a creatinine clearance byCockcroft-Gault formula <30 mL/min.
Pregnancy, breast feeding or may be considering pregnancy during the study period orwomen of childbearing potential unwilling to use appropriate contraception duringsex;
The use of medication with known drug-to-drug interactions (including but notlimited to erythromycin or clarithromycin).
Unable or unwilling to provide consent.
Study Design
Study Description
Connect with a study center
The Ottawa Hospital General Campus
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
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