Clinical trials: Colchicine
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
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
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, 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.
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.
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.
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.
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.
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.