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Generated: December 14, 2018

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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.
NCT01112982 An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. Completed University of South Florida 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.
NCT01123395 Bioavailability Study of Colcrys® in Apple Juice Completed Mutual Pharmaceutical Company, Inc. Phase 1 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Colcrys

Condition Name

Condition Name for Colcrys
Intervention Trials
Healthy 4
Gout 3
Coronary Artery Disease 3
Manipulation Under Anesthesia 1
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Condition MeSH

Condition MeSH for Colcrys
Intervention Trials
Myocardial Ischemia 3
Coronary Disease 3
Coronary Artery Disease 3
Gout 2
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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
National Heart, Lung, and Blood Institute (NHLBI) 2
Takeda 2
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Sponsor Type

Sponsor Type for Colcrys
Sponsor Trials
Other 11
Industry 7
NIH 5
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Queensland Health
Farmers Insurance
Dow
UBS
Fish and Richardson
Fuji
McKinsey
Merck

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