This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group,
dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4. 8
mg) versus low-dose colchicine (1. 8 mg) or placebo for acute gout flares.
The pain score was based on a scale of 1 - 10 where 1 was no pain and 10 was the worst pain
imaginable. Efficacy was defined as a 50% reduction in pain score in the target joint at 24
hours in patients who did not use rescue medicine. The primary efficacy analysis was to be
based on an Intent-to-Treat (ITT) population, defined as all patients who were randomized,
contacted the Call Center, and were instructed to begin taking study drug. An otherwise
qualified patient was excluded from the ITT population only if the patient returned a study
drug blister pack completely unused.
Secondary outcome measures compared the efficacy of STD dose colchicine to a low dose
regimen and placebo using the same criteria for efficacy as for the primary outcome measure.
Additional secondary outcome measures were time to 50% and 90% reduction in pain in the
target joint analyzed by treatment group using Kaplan-Meier methods, and the change in mean
pain intensity from 0 to 72 hours plotted by time point for each treatment group.
All safety analyses were carried out using the safety population defined as all patients who
received at least one dose of study medication regardless of authorization by the Call
Center To determine the safety of colchicine when administered via two different dose
regimens all patients who had a gout flare were seen by the investigator as soon as possible
after onset and evaluated until the flare and any adverse events resolved. All adverse
effects, whether recorded by the patient in the diary or obtained by systematic evaluation
by the investigator were recorded and reported in tabular form. Treatment-emergent adverse
events (TEAE) were summarized by MedDRA System Organ Class and preferred terms and tabulated
according treatment arm, overall incidence, severity and relationship to study medication.
Multiple events within a patient were counted once and at greatest severity and closest
relationship to study medication.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Birmingham, Alabama, United States
Innovative Clinical Trials, Birmingham, Alabama 35205, United States
Tomac, Inc., Columbiana, Alabama 35051, United States
Rheumatology Associates of North Alabama, Huntsville, Alabama 35801, United States
Tucson, Arizona, United States
Genova Clinical Research, Tucson, Arizona 85741, United States
NEA Clinic, Jonesboro, Arkansas 72401, United States
Arkansas Primary Care Clinic, Little Rock, Arkansas 72204, United States
Irvine Center for Clinical Research, Irvine, California 92618, United States
La Jolla, California, United States
Paramount, California, United States
Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California 91730, United States
San Diego, California, United States
West Covina, California, United States
Florida Medical Center, Clearwater, Florida 33755, United States
Nature Coast Clinical Research, Crystal River, Florida 34429, United States
Southeastern Integrated Medical, Gainesville, Florida 32607, United States
George E. Platt, MD, Green Cove Springs, Florida 32043, United States
Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States
Health Awareness, Inc., Jupiter, Florida 33458, United States
Lake Mary, Florida, United States
Medical Research Trust, Lake Worth, Florida 33461, United States
Hillcrest Medical Center, Orange City, Florida 32763, United States
Farmer MD, PA, Ormond Beach, Florida 32174, United States
Coastal Medical Research, Inc., Port Orange, Florida 32127, United States
Southwest Florida Clinical Research Center, Tampa, Florida 33609, United States
Geodessey Research, LLC, Vero Beach, Florida 32960, United States
Bond Clinic, Winter Haven, Florida 33880, United States
Global Research Partners & Consultants, Inc., Calhoun, Georgia 30701, United States
Decatur, Georgia, United States
North Georgia Rheumatology Group, PC, Lawrenceville, Georgia 30045, United States
Arthritis & Osteoporosis Center of South Georgia, Tifton, Georgia 31794, United States
Boise, Idaho, United States
Idaho Arthritis & Osteoporosis Center, Meridian, Idaho 83642, United States
Lake County Research Associates, Libertyville, Illinois 60048, United States
Moline, Illinois, United States
Physicians Clinic of Iowa, Cedar Rapids, Iowa 52401, United States
The Center for Arthritis & Osteoporosis, Elizabethtown, Kentucky 42701, United States
David H. Neustadt PSCq, Louisville, Kentucky 40202, United States
Gulf Coast Research, Baton Rouge, Louisiana 70808, United States
Arthritis and Osteoporosis Center of Maryland, Frederick, Maryland 21702, United States
Rockville, Maryland, United States
The Center for Rheumatology & Bone Research, Wheaton, Maryland 20902, United States
Future Care Studies, Springfield, Massachusetts 01103, United States
Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States
Justus Fiechtner, MD, MPH, Lansing, Michigan 48910, United States
Arthritis Associates, Hattiesburg, Mississippi 39402, United States
Medical Center Healthcare Research, Florissant, Missouri 63031, United States
Medex Healthcare, Saint Louis, Missouri 63117, United States
Las Vegas, Nevada, United States
Arthritis Center of Reno, Reno, Nevada 89502, United States
Arthritis & Osteoporisis Associates, Manalapan, New Jersey 07726, United States
Rheumatology and Arthritis Associates, Medford, New Jersey 08055, United States
Voorhees, New Jersey, United States
Albany, New York, United States
Southwest Medical Associates, Brewster, New York 10509, United States
Concorde medical Group, New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Williamsville, New York, United States
Arthritis Consultants of the Carolinas, Belmont, North Carolina 28012, United States
Arthritis & Osteoporosis Consultants of the Carolinas, Charlotte, North Carolina 28207, United States
Dayton, Ohio, United States
Mayfield Village, Ohio, United States
Middleburg Heights, Ohio, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Orangeburg, South Carolina, United States
Milan, Tennessee, United States
New Tazewell, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Carrollton, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Sugarland, Texas, United States
Ettrick, Virginia, United States
Portsmouth, Virginia, United States
Reston, Virginia, United States
Suffolk, Virginia, United States