Clinical trials: Colchicine
Familial Mediterranean Fever, FMF
Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever
The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance…
- Trial name
- NCT05190991
- Testing
- RPH-104
- Where
- 8 sites in Armenia, Russia and 1 more
- Volunteers
- 60 people
- Sponsor
- R-Pharm International, LLC
Familial Mediterranean Fever (FMF )
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with colchicine-resistand Familial Mediterranian Fever (FMF).
- Trial name
- NCT06666335
- Testing
- Anakinra
- Sponsor
- Swedish Orphan Biovitrum
Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp.
- Trial name
- NCT00983372
- Testing
- Colchicine, Diltiazem ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
COVID-19 Pneumonia
Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.
Colchicine acts upstream in the cytokines cascade by inhibiting the NLRP3 inflammasome while IL-6 receptor antagonists (tocilizumab) block the end result of the cytokines cascade.
- Trial name
- NCT05118737
- Testing
- Colchicine
- Where
- Qatar
- Volunteers
- 230 people
- Sponsor
- Hamad Medical Corporation
Gout
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
- Trial name
- NCT03131583
- Testing
- Colchicine, Febuxostat, SHR4640
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Colchicine Resistant/Intolerant Familial Mediterranean Fever
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment.
- Trial name
- CONTROL FMF (NCT01148797)
- Testing
- Canakinumab
- Where
- 5 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Gout
Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout
A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with…
- Trial name
- NCT02330796
- Testing
- Bucillamine, Colchicine
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Revive Therapeutics, Ltd.
Atrial Fibrillation
COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF
There is substantial evidence linking inflammation to the initiation and perpetuation of AF. Although the precise mechanism by which inflammation contributes to the development of AF remains unclear, it has been proposed that…
- Trial name
- COPPER-AF (NCT02582190)
- Testing
- Colchicine group
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Familial Mediterranean Fever, FMF
Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine
Study purpose is an evaluation of efficacy and safety of RPH-104 in the population of subjects with Familial Mediterranean Fever (FMF) with colchicine resistance or intolerance(i.e. colchicine resistant (crFMF)..
- Trial name
- NCT05092776
- Testing
- RPH-104
- Where
- 14 sites in Armenia, Georgia and 2 more
- Volunteers
- 84 people
- Sponsor
- R-Pharm International, LLC
Healthy
Bioequivalence Study of Colchicine Tablets
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with…
- Trial name
- NCT01021020
- Testing
- Colchicine, Colchicine/Probenecid
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Study Between Colchicine and Ketoconazole
Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine.
- Trial name
- NCT00983216
- Testing
- Colchicine, Ketoconazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of…
- Trial name
- NCT01001052
- Testing
- Colcrys™ (colchicine)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Between Colchicine and Ritonavir
Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the pharmacokinetic profile of a single 0.6 mg dose…
- Trial name
- NCT00983515
- Testing
- Colchicine, Ritonavir
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at steady state on the steady state pharmacokinetic profile of ethinyl estradiol and norethindrone (Ortho-Novum 1/35).
- Trial name
- NCT01040845
- Testing
- Norethindrone/Ethinyl Estradiol, Colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Study of Colchicine and Clarithromycin
Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across…
- Trial name
- NCT00984061
- Testing
- colchicine, clarithromycin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Intercritical Gout
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
- Trial name
- NCT01451645
- Testing
- Colchicine (Colcrys®), allopurinol
- Where
- 37 sites in United States
- Volunteers
- 82 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy
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
- NCT01601132
- Testing
- theophylline, colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine.
- Trial name
- NCT00960193
- Testing
- Colchicine, Seville Orange Juice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Study of Colchicine and Azithromycin
Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine.
- Trial name
- NCT00983294
- Testing
- Colchicine, Azithromycin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Between Colchicine and Verapamil ER
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp.
- Trial name
- NCT00983242
- Testing
- Colchicine, Verapamil HCl ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.