MedPath

Colchicine

Generic Name
Colchicine
Brand Names
Colcrys, Gloperba, Lodoco, Mitigare
Drug Type
Small Molecule
Chemical Formula
C22H25NO6
CAS Number
64-86-8
Unique Ingredient Identifier
SML2Y3J35T
Background

Colchicine is an alkaloid drug derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus." Its use was first approved by the FDA in 1961. Colchicine is used in the treatment of gout flares and Familial Mediterranean fever, and prevention of major cardiovascular events. It has also been investigated in other inflammatory and fibrotic conditions.

Indication

Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older. It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.

Associated Conditions
Behcet's Syndrome, Cardiovascular Mortality, Coronary Revascularization, Familial Mediterranean Fever (FMF ), Gout Flares, Myocardial Infarction, Pericarditis, Postpericardiotomy Syndrome, Stroke

Drug Interaction Study of Colchicine and Theophylline

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-05-17
Last Posted Date
2013-06-17
Lead Sponsor
Takeda
Target Recruit Count
30
Registration Number
NCT01601132
Locations
🇺🇸

Worlwide Clinical Trials Drug Development Solutions, Clinical Research Services, San Antonio, Texas, United States

COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

Phase 3
Conditions
Cardiac Surgery
Post-pericardiotomy Syndrome
Atrial Fibrillation
Pericardial Effusion
Pleural Effusion
Interventions
Drug: Placebo
First Posted Date
2012-03-13
Last Posted Date
2014-07-01
Lead Sponsor
Maria Vittoria Hospital
Target Recruit Count
360
Registration Number
NCT01552187
Locations
🇮🇹

Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy

Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Phase 2
Withdrawn
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-11-29
Last Posted Date
2013-09-27
Lead Sponsor
Milton S. Hershey Medical Center
Registration Number
NCT01481233

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

Phase 4
Completed
Conditions
Intercritical Gout
Interventions
First Posted Date
2011-10-14
Last Posted Date
2014-05-12
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
82
Registration Number
NCT01451645

Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

Phase 2
Completed
Conditions
Hyperuricemia
Gout
Interventions
First Posted Date
2011-08-15
Last Posted Date
2015-04-03
Lead Sponsor
CymaBay Therapeutics, Inc.
Target Recruit Count
27
Registration Number
NCT01416402

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Phase 2
Completed
Conditions
Gout
Interventions
First Posted Date
2011-07-21
Last Posted Date
2015-09-18
Lead Sponsor
CymaBay Therapeutics, Inc.
Target Recruit Count
100
Registration Number
NCT01399008

Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout

Phase 2
Completed
Conditions
Hyperuricemia
Gout
Interventions
Drug: Placebo comparator
First Posted Date
2011-04-18
Last Posted Date
2015-04-17
Lead Sponsor
CymaBay Therapeutics, Inc.
Target Recruit Count
67
Registration Number
NCT01336686

A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.

Phase 4
Completed
Conditions
Chronic Kidney Disease
Interventions
First Posted Date
2010-07-30
Last Posted Date
2010-12-29
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
80
Registration Number
NCT01173107
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-25
Last Posted Date
2011-05-12
Lead Sponsor
Mutual Pharmaceutical Company, Inc.
Target Recruit Count
16
Registration Number
NCT01130051
Locations
🇺🇸

Novum Pharmaceutical Research Services, Las Vegas, Nevada, United States

Bioavailability Study of Colcrys® in Apple Juice

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-14
Last Posted Date
2011-05-03
Lead Sponsor
Mutual Pharmaceutical Company, Inc.
Target Recruit Count
16
Registration Number
NCT01123395
Locations
🇺🇸

Novum Pharmaceutical Research Services, Las Vegas, Nevada, United States

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