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CLINICAL TRIALS PROFILE FOR COLCRYS

All Clinical Trials for Colcrys

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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.
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