Clinical trials: Colchicine
Familial Mediterranean Fever
Rilonacept for Treatment of Familial Mediterranean Fever (FMF)
Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash.
- Trial name
- NCT00582907
- Testing
- Rilonacept
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- The Cleveland Clinic
Pharmacokinetics, Healthy
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp.
- Trial name
- NCT00983931
- Testing
- Colchicine, Cyclosporine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Gouty Arthritis
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent…
- Trial name
- NCT01362608
- Testing
- Canakinumab, ACZ885, Triamcinolone acetonide
- Where
- 20 sites in Argentina, China and 2 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation, Atrial Flutter
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major thoracic surgery.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Myocardial Injury After Non-Cardiac Surgery
- Trial name
- COP-AF (NCT03310125)
- Testing
- Active Colchicine
- Where
- 46 sites in United States, Austria and 9 more
- Volunteers
- 3,209 people
- Sponsor
- Population Health Research Institute
Obesity, Metabolic Disease
Effects of Colchicine in Non-Diabetic Adults With Metabolic Syndrome
Background: Being overweight may cause low-level inflammation. This inflammation may cause some of the medical problems of obesity, like high blood sugar (diabetes) and heart disease.
- Trial name
- NCT02153983
- Testing
- Colchicine 0.6Mg Cap, Colchicine 0.6Mg Tab
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
SARS-CoV-2
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized patients with SARS-CoV-2
- Trial name
- COLSTAT (NCT04472611)
- Testing
- Standard of Care (SOC) and Colchicine+Rosuvastatin
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- Yale University
Pharmacokinetics
Pharmacokinetic Study With Colchicine in Healthy Volunteers
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12…
- Trial name
- NCT01017003
- Testing
- colchicine tablets
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Coronary Artery Disease
Anti-inflammatory Effects of Colchicine in PCI
Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death.
- Trial name
- NCT01709981
- Testing
- Colchicine
- Where
- 3 sites in United States
- Volunteers
- 280 people
- Sponsor
- NYU Langone Health
Healthy
Bioavailability Study of Colcrys® in Apple Juice
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact…
- Trial name
- NCT01123395
- Testing
- colchicine 0.6 mg tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Coronavirus Infection
COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19
The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality.
- Trial name
- COMBATCOVID19 (NCT04363437)
- Testing
- Colchicine, Usual Care
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Maimonides Medical Center
Healthy
Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive and mechanism-based inhibitors (MBI).
- Trial name
- NCT00960323
- Testing
- Colchicine, Atorvastatin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Coronary Artery Disease, Acute Coronary Syndrome
Colchicine in Percutaneous Coronary Intervention
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused…
- Trial name
- Colchicine-PCI (NCT02594111)
- Where
- United States
- Volunteers
- 714 people
- Sponsor
- VA Office of Research and Development
Coronary Artery Disease, Myocardial Infarction
Colchicine Cardiovascular Outcomes Trial (COLCOT)
The study evaluates whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction.
- Trial name
- COLCOT (NCT02551094)
- Testing
- colchicine
- Where
- Canada
- Volunteers
- 4,745 people
- Sponsor
- Montreal Heart Institute
Pharmacokinetics
Drug-Drug Interaction Study of Colchicine and Theophylline
Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction.
- Trial name
- NCT00983905
- Testing
- Theophylline, Colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Acute Gout
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine.
- Trial name
- NCT00798369
- Testing
- Canakinumab, Triamcinolone acetonide
- Where
- 75 sites in United States, Argentina and 9 more
- Volunteers
- 200 people
- Sponsor
- Novartis
Corona Virus Infection
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion.
- Trial name
- COVID-19 (NCT04322682)
- Testing
- Colchicine
- Where
- 32 sites in United States, Brazil and 4 more
- Volunteers
- 4,506 people
- Sponsor
- Montreal Heart Institute
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study
The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom…
- Trial name
- β-RELIEVED (NCT01029652)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 47 sites in Australia, Belgium and 15 more
- Volunteers
- 230 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
In this randomized controlled clinical trial, defined cases of COVID-19 with mild, moderate, or severe pneumonia (according to the NIH guideline) were treated with conventional treatment regimens (controls) as well as in…
- Trial name
- NCT04392141
- Testing
- Standard Treatment, Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
- Where
- Iran
- Volunteers
- 120 people
- Sponsor
- Kermanshah University of Medical Sciences
Periodic Fevers Syndrome
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301…
- Trial name
- NCT02911857
- Testing
- Canakinumab (AIN457)
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm).
- Trial name
- COLHEART-19 (NCT04355143)
- Testing
- Colchicine Tablets, Current care per UCLA treating physicians
- Where
- 3 sites in United States
- Volunteers
- 93 people
- Sponsor
- University of California, Los Angeles