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
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
- Conditions
- Gout
- Interventions
- First Posted Date
- 2010-04-29
- Last Posted Date
- 2019-08-07
- Lead Sponsor
- University of South Florida
- Target Recruit Count
- 74
- Registration Number
- NCT01112982
- Locations
- 🇺🇸
University of South Florida Medical Clinics, Tampa, Florida, United States
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
- First Posted Date
- 2010-03-10
- Last Posted Date
- 2012-10-12
- Lead Sponsor
- Takeda
- Target Recruit Count
- 40
- Registration Number
- NCT01084278
- Locations
- 🇺🇸
West Coast Clinical Trials, Cypress, California, United States
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
- Conditions
- Familial Mediterranean Fever
- Interventions
- First Posted Date
- 2010-02-25
- Last Posted Date
- 2012-01-10
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 75
- Registration Number
- NCT01075906
- Locations
- 🇮🇱
Soroka Medical Center, Beer Sheba, Israel
🇮🇱Safra Children's Hospital, Tel Hashomer, Israel
🇹🇷Hacettepe University, Ankara, Turkey
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
- Conditions
- Pharmacokinetics
- Interventions
- First Posted Date
- 2009-12-30
- Last Posted Date
- 2010-01-05
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 30
- Registration Number
- NCT01040845
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Bioequivalence Study of Colchicine Tablets
- First Posted Date
- 2009-11-26
- Last Posted Date
- 2009-12-09
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 28
- Registration Number
- NCT01021020
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study
- First Posted Date
- 2009-11-23
- Last Posted Date
- 2009-12-01
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 18
- Registration Number
- NCT01018420
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Pharmacokinetic Study With Colchicine in Healthy Volunteers
- First Posted Date
- 2009-11-20
- Last Posted Date
- 2009-11-20
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 14
- Registration Number
- NCT01017003
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Pharmacokinetic Study of an Acute Gout Regimen
- First Posted Date
- 2009-11-20
- Last Posted Date
- 2009-11-20
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT01017042
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Colchicine for Diabetic Nephropathy
- First Posted Date
- 2009-10-30
- Last Posted Date
- 2013-01-04
- Lead Sponsor
- Prof.Avi Livneh
- Target Recruit Count
- 12
- Registration Number
- NCT01005121
- Locations
- 🇮🇱
Sheba medical center, Tel hashomer, Ramat gan, Israel
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
- First Posted Date
- 2009-09-24
- Last Posted Date
- 2009-10-15
- Lead Sponsor
- Mutual Pharmaceutical Company, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT00983931
- Locations
- 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States
Drug Development Updates
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