MPC-004 for the Treatment of an Acute Gout Flare
AGREE
A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 1 Week, Dose Comparison Study to Evaluate the Efficacy, Safety, and Tolerability of MPC-004 in Patients With an Acute Gout Flare
1 other identifier
interventional
185
1 country
83
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2007
Shorter than P25 for phase_3
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 23, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
September 22, 2009
CompletedNovember 1, 2012
October 1, 2012
6 months
July 23, 2007
August 12, 2009
October 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Responders
Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.
24 hours after baseline
Study Arms (3)
High Dose Colchicine
EXPERIMENTALAfter confirmation of a gout flare, patients were to begin standard dosing of colchicine 4.8mg (two capsules (1.8mg) initially followed by additional one capsule doses (0.6mg) every hour for an additional 6 doses).
Low Dose Colchicine
EXPERIMENTALWithin 12 hours of a confirmed gout flare, patients were to begin the low dose colchicine regimen consisting of a total dose of 1.8 mg - two colchicine capsules initially (1.2 mg)followed an hour later by a single additional capsule of active drug(0.6 mg)then by 5 additional hourly doses of an identical looking placebo capsules
Placebo
PLACEBO COMPARATORInterventions
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.
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
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.
Eligibility Criteria
You may qualify if:
- Patients of either gender and of any race ≥18 years of age.
- If female, patients must be postmenopausal as evidenced by lack of menses for ≥12 consecutive months.
- Patients must present with a confirmed diagnosis of gout.
- Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months prior to randomization.
- Patients on urate lowering therapy must be on a stable dose and schedule with no changes in therapy for 4 weeks prior to randomization and expected to remain on a stable regimen during study participation.
- Patients must be willing to adhere to the study schedule and the protocol requirements.
- Patients must be willing and able to give written informed consent. A HIPAA and/or state privacy consent must also be signed.
You may not qualify if:
- Patients with acute polyarticular gout (\>4 joints).
- Patients who have experienced \>2 acute gouty arthritic attacks per month, or \>12 attacks overall, in the 6 months prior to randomization.
- Patients with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion.
- Patients with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening.
- Patients with active myeloid leukemia, obstructive gastrointestinal cancer, or metastatic cancer.
- Patients with chronic renal dysfunction (creatinine clearance \<60 mL/min as estimated with the Cockcroft Gault formula).
- Patients with chronic hepatic dysfunction.
- Patients with a history of alcohol or substance abuse within the 12 months prior to randomization.
- Patients who have any concomitant illness or other finding that, in the opinion of the Investigator, would confound the study data or place the patient at unacceptable risk if the patient were to participate in the study, or that would require frequent adjustments in concomitant medications during the course of the study.
- Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept, infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants (warfarin, heparin, low molecular weight heparin \[LMWH\], antithrombin agents, thrombin inhibitors, or selective Factor Xa inhibitors \[note, use of aspirin ≤325 mg/day is allowed\]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs), acetaminophen, tramadol, and other analgesics such as opiates at screening
- Use of any investigational drug within 30 days prior to randomization.
- Patients currently participating in another research study or anticipated to enroll in such during participation in this study.
- Patients for whom informed consent cannot be obtained.
- Patients who have previously been randomized into this study and begun ingestion of study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (83)
Innovative Clinical Trials
Birmingham, Alabama, 35205, United States
Unknown Facility
Birmingham, Alabama, United States
Tomac, Inc.
Columbiana, Alabama, 35051, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Genova Clinical Research
Tucson, Arizona, 85741, United States
Unknown Facility
Tucson, Arizona, 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
Unknown Facility
La Jolla, California, United States
Unknown Facility
Paramount, California, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
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
Unknown Facility
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
Unknown Facility
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
Unknown Facility
Boise, Idaho, United States
Idaho Arthritis & Osteoporosis Center
Meridian, Idaho, 83642, United States
Lake County Research Associates
Libertyville, Illinois, 60048, United States
Unknown Facility
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
Unknown Facility
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
St Louis, Missouri, 63117, United States
Unknown Facility
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
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Albany, New York, United States
Southwest Medical Associates
Brewster, New York, 10509, United States
Concorde medical Group
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
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
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Mayfield Village, Ohio, United States
Unknown Facility
Middleburg Heights, Ohio, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Harleysville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Orangeburg, South Carolina, United States
Unknown Facility
Milan, Tennessee, United States
Unknown Facility
New Tazewell, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Sugarland, Texas, United States
Unknown Facility
Ettrick, Virginia, United States
Unknown Facility
Portsmouth, Virginia, United States
Unknown Facility
Reston, Virginia, United States
Unknown Facility
Suffolk, Virginia, United States
Related Publications (1)
Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010 Apr;62(4):1060-8. doi: 10.1002/art.27327.
PMID: 20131255DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- AR Scientific, Inc.
Study Officials
- STUDY CHAIR
Matthew W Davis, MD, RPh
AR Scientific, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 23, 2007
First Posted
July 25, 2007
Study Start
April 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
November 1, 2012
Results First Posted
September 22, 2009
Record last verified: 2012-10