185
Participants
Start Date
April 30, 2007
Primary Completion Date
October 31, 2007
Study Completion Date
October 31, 2007
High Dose Colchicine (4.8 mg total dose)
At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
Low Dose Colchicine (1.8mg total dose)
At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center
Placebo Control
At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
Southwest Medical Associates, Brewster
The Center for Rheumatology & Bone Research, Wheaton
Arthritis and Osteoporosis Center of Maryland, Frederick
Arthritis Consultants of the Carolinas, Belmont
Arthritis & Osteoporosis Consultants of the Carolinas, Charlotte
North Georgia Rheumatology Group, PC, Lawrenceville
Global Research Partners & Consultants, Inc., Calhoun
Arthritis & Osteoporosis Center of South Georgia, Tifton
George E. Platt, MD, Green Cove Springs
Coastal Medical Research, Inc., Port Orange
Farmer MD, PA, Ormond Beach
Jacksonville Center for Clinical Research, Jacksonville
Southeastern Integrated Medical, Gainesville
Hillcrest Medical Center, Orange City
Geodessey Research, LLC, Vero Beach
Health Awareness, Inc., Jupiter
Medical Research Trust, Lake Worth
Southwest Florida Clinical Research Center, Tampa
Florida Medical Center, Clearwater
Bond Clinic, Winter Haven
Nature Coast Clinical Research, Crystal River
Tomac, Inc., Columbiana
Innovative Clinical Trials, Birmingham
Rheumatology Associates of North Alabama, Huntsville
Arthritis Associates, Hattiesburg
David H. Neustadt PSCq, Louisville
The Center for Arthritis & Osteoporosis, Elizabethtown
Justus Fiechtner, MD, MPH, Lansing
Physicians Clinic of Iowa, Cedar Rapids
Lake County Research Associates, Libertyville
Medical Center Healthcare Research, Florissant
Medex Healthcare, St Louis
Gulf Coast Research, Baton Rouge
Arkansas Primary Care Clinic, Little Rock
NEA Clinic, Jonesboro
Idaho Arthritis & Osteoporosis Center, Meridian
Genova Clinical Research, Tucson
Arthritis Center of Reno, Reno
Rancho Cucamonga Clinical Trials, Rancho Cucamonga
Irvine Center for Clinical Research, Irvine
Birmingham
Tucson
La Jolla
Paramount
San Diego
West Covina
Lake Mary
Decatur
Boise
Moline
Rockville
Las Vegas
Voorhees Township
Albany
Concorde medical Group, New York
Rochester
Syracuse
Williamsville
Dayton
Mayfield Village
Middleburg Heights
Duncansville
Harleysville
Philadelphia
Orangeburg
Milan
New Tazewell
Arlington
Austin
Carrollton
Fort Worth
Houston
Irving
San Antonio
Sugarland
Ettrick
Portsmouth
Reston
Suffolk
Future Care Studies, Springfield
Clinical Pharmacology Study Group, Worcester
Arthritis & Osteoporisis Associates, Manalapan
Rheumatology and Arthritis Associates, Medford
Lead Sponsor
Takeda
INDUSTRY