A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects with acute gout. Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with acute gout. The primary efficacy measurement will be pain score after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
ABP-745 Dose A + Colchicine placebo - tablets (PO)
ABP-745 Dose B + Colchicine placebo - tablets (PO)
ABP-745 placebo + Colchicine - tablets (PO)
ABP-745 placebo + Colchicine placebo - tablets (PO)
Onyx Clinical Research
Peoria, Arizona, United States
RECRUITINGExinia Research
La Mesa, California, United States
RECRUITINGEvergreen Clinical Trial
Norcross, Georgia, United States
NOT_YET_RECRUITINGBioluminux Clinical Research
Naperville, Illinois, United States
Change in Visual Analog Scale (VAS) pain score of the target joint
Change from baseline in 0-100 mm VAS pain score of the target joint
Time frame: 24 hours post the first dose of study drug
Change and percentage change from baseline in VAS pain score of the target joint
Time frame: 2-8 days post the first dose of study drug
Incidence of treatment-emergent adverse events (Safety and Tolerability)
TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.
Time frame: up to 14 days post the first dose of study drug
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Exinia Research
Des Moines, Iowa, United States
RECRUITINGNorthshore Research Associates
Alexandria, Louisiana, United States
RECRUITINGDelRicht Research
Baton Rouge, Louisiana, United States
RECRUITINGDelRicht Research
New Orleans, Louisiana, United States
RECRUITINGInterphase Clinical Trials
Lutherville, Maryland, United States
RECRUITINGDelRicht Research Gulfport
Gulfport, Mississippi, United States
RECRUITING...and 28 more locations