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CLINICAL TRIALS PROFILE FOR COLCRYS

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Clinical Trials for Colcrys

Trial ID	Title	Status	Sponsor	Phase	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	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	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	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.

Clinical Trial Conditions for Colcrys

Condition Name

Condition Name for Colcrys
Intervention	Trials
Healthy	4
Gout	3
Coronary Artery Disease	3

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Condition MeSH

Condition MeSH for Colcrys
Intervention	Trials
Myocardial Ischemia	3
Coronary Disease	3
Coronary Artery Disease	3

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Clinical Trial Locations for Colcrys

Trials by Country

Trials by Country for Colcrys
Location	Trials
United States	12
China	1

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Trials by US State

Trials by US State for Colcrys
Location	Trials
New York	3
Maryland	2
Nevada	2
Florida	2
California	2

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Clinical Trial Progress for Colcrys

Clinical Trial Phase

Clinical Trial Phase for Colcrys
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	6
Phase 1	3

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Clinical Trial Status

Clinical Trial Status for Colcrys
Clinical Trial Phase	Trials
Completed	9
Recruiting	5
Withdrawn	1

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Clinical Trial Sponsors for Colcrys

Sponsor Name

Sponsor Name for Colcrys
Sponsor	Trials
Mutual Pharmaceutical Company, Inc.	3
Takeda	2
New York University School of Medicine	2

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Sponsor Type

Sponsor Type for Colcrys
Sponsor	Trials
Other	11
Industry	7
NIH	5

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