Clinical trials: Colchicine
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.
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Ilaris NIS in Korea
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes…
- Conditions
- Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS)
- Trial name
- REASSURE (NCT06838143)
- Testing
- Ilaris
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or…
- Trial name
- NCT01075906
- Testing
- colchicine sprinkle capsules
- Where
- 10 sites in United States, Armenia and 2 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
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
Healthy
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
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 sprinkled on applesauce (1 tablespoon) relative to the same dose given as…
- Trial name
- NCT01130051
- Testing
- Colchicine 0.6 mg tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
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
Pharmacokinetics
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
Grapefruit juice is an inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine.
- Trial name
- NCT00984009
- Testing
- Colchicine, Grapefruit Juice
- Where
- United States
- 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.
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
Pharmacokinetics
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal…
- Trial name
- NCT01084278
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Acute Gouty Arthritis Flares
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any…
- Trial name
- β-RELIEVED (NCT01470989)
- Testing
- ACZ885, Triamcinolone acetonide 40 mg
- Where
- 56 sites in United States, Australia and 7 more
- Volunteers
- 136 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.
Familial Mediterranean Fever, FMF
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
The primary objective is to evaluate the main pharmacokinetic (PK) parameters, efficacy, and safety of goflikicept (GFC) in children and adolescents with colchicine-resistant or colchicine-intolerant familial Mediterranean fever…
- Trial name
- NCT07880886
- Testing
- RPH-104
- Where
- 3 sites in Russia
- Volunteers
- 18 people
- Sponsor
- R-Pharm
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
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
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.
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
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.
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
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