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CLINICAL TRIALS PROFILE FOR COLCRYS
All Clinical Trials for Colcrys
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01001052 ↗ | Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions | Completed | Mutual Pharmaceutical Company, Inc. | Phase 1 | 2009-10-01 | 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 older, generally healthy subjects 60 years of age or older following an overnight fast. |
| NCT01084278 ↗ | Healthy and Renal Impairment Study of Colcrys (Colchicine, USP) | Completed | Takeda | Phase 4 | 2010-05-01 | 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 function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population. |
| NCT01112982 ↗ | An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. | Completed | Takeda Pharmaceuticals North America, Inc. | Phase 4 | 2010-05-01 | The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI. |
| NCT01112982 ↗ | An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. | Completed | University of South Florida | Phase 4 | 2010-05-01 | The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI. |
| NCT01123395 ↗ | Bioavailability Study of Colcrys® in Apple Juice | Completed | Mutual Pharmaceutical Company, Inc. | Phase 1 | 2010-05-01 | 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 tablet to healthy subjects following an overnight fast. |
| NCT01130051 ↗ | Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce | Completed | Mutual Pharmaceutical Company, Inc. | Phase 1 | 2010-05-01 | 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 an intact tablet to healthy subjects following an overnight fast. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period. |
| NCT01416402 ↗ | Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients | Completed | CymaBay Therapeutics, Inc. | Phase 2 | 2011-08-01 | The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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