MPC-004 for the Treatment of an Acute Gout Flare

Last updated: October 30, 2012
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Bone Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00506883
MPC 004-06-3001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients of either gender and of any race ≥18 years of age.

  2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12consecutive months.

  3. Patients must present with a confirmed diagnosis of gout.

  4. Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months priorto randomization.

  5. Patients on urate lowering therapy must be on a stable dose and schedule with nochanges in therapy for 4 weeks prior to randomization and expected to remain on astable regimen during study participation.

  6. Patients must be willing to adhere to the study schedule and the protocolrequirements.

  7. Patients must be willing and able to give written informed consent. A HIPAA and/orstate privacy consent must also be signed.

Exclusion

Exclusion Criteria:

  1. Patients with acute polyarticular gout (>4 joints).

  2. Patients who have experienced >2 acute gouty arthritic attacks per month, or >12attacks overall, in the 6 months prior to randomization.

  3. Patients with arthritis due to any cause other than gout that may confound any studyassessments per Investigator discretion.

  4. Patients with a history of myocardial infarction, unstable angina, cerebrovascularevents, or coronary artery bypass grafting within the previous 6 months prior toscreening.

  5. Patients with active myeloid leukemia, obstructive gastrointestinal cancer, ormetastatic cancer.

  6. Patients with chronic renal dysfunction (creatinine clearance <60 mL/min as estimatedwith the Cockcroft Gault formula).

  7. Patients with chronic hepatic dysfunction.

  8. Patients with a history of alcohol or substance abuse within the 12 months prior torandomization.

  9. Patients who have any concomitant illness or other finding that, in the opinion of theInvestigator, would confound the study data or place the patient at unacceptable riskif the patient were to participate in the study, or that would require frequentadjustments in concomitant medications during the course of the study.

  10. Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept,infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants (warfarin, heparin, low molecular weight heparin [LMWH], antithrombin agents, thrombininhibitors, or selective Factor Xa inhibitors [note, use of aspirin ≤325 mg/day isallowed]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs),acetaminophen, tramadol, and other analgesics such as opiates at screening

  11. Use of any investigational drug within 30 days prior to randomization.

  12. Patients currently participating in another research study or anticipated to enroll insuch during participation in this study.

  13. Patients for whom informed consent cannot be obtained.

  14. Patients who have previously been randomized into this study and begun ingestion ofstudy drug.

Study Design

Total Participants: 185
Study Start date:
April 01, 2007
Estimated Completion Date:
October 31, 2007

Study Description

This study is a multi-center, randomized, double-blind, placebo-controlled, parallel group trial to compare the efficacy and safety of standard-dose colchicine (STD)(total dose = 4.8 mg) versus low-dose colchicine (total dose 1.8 mg) or placebo for the treatment of acute gout flares. Eight hundred and thirteen patients with a confirmed diagnosis of gout were screened. 238 of the screened patients failed screening; 235(98.7%) failed because they did not meet inclusion/exclusion criteria. The 575 eligible patients were randomly assigned (1:1:1) to one of three treatment groups . At the randomization visit the investigator dispensed a blister card containing eight identical looking capsules (in a combination of active drug and placebo capsules) in a double blind fashion for use during their next gout flare. Patients were instructed to self-initiate treatment with the study medication within 12 hours of a gout flare onset. Gout flares were determined by calling a Gout Flare Call Center established for this purpose. At Investigator discretion, rescue medication could also be provided, but patients were encouraged not to use rescue medication within the first 24 hours after starting treatment with study drug. Of the 575 study participants, 185 had a qualifying gout flare and 390 did not. Patients used a diary to record study drug administration, pain score, the presence or absence of gastrointestinal adverse events (nausea, vomiting, diarrhea, and abdominal pain) and the timing of any rescue medication use prior to beginning treatment and 1, 2, 3, 4, 5, 6, 7, 8, 16, 24, 32, 40, 48, 56, 64, and 72 hours after the start of dosing.

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.

Connect with a study center

  • Innovative Clinical Trials

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Tomac, Inc.

    Columbiana, Alabama 35051
    United States

    Site Not Available

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Genova Clinical Research

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • NEA Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Irvine Center for Clinical Research

    Irvine, California 92618
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Paramount, California
    United States

    Site Not Available

  • Rancho Cucamonga Clinical Trials

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • West Covina, California
    United States

    Site Not Available

  • Florida Medical Center

    Clearwater, Florida 33755
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Southeastern Integrated Medical

    Gainesville, Florida 32607
    United States

    Site Not Available

  • George E. Platt, MD

    Green Cove Springs, Florida 32043
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Health Awareness, Inc.

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Lake Mary, Florida
    United States

    Site Not Available

  • Medical Research Trust

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Hillcrest Medical Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Farmer MD, PA

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Coastal Medical Research, Inc.

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Southwest Florida Clinical Research Center

    Tampa, Florida 33609
    United States

    Site Not Available

  • Geodessey Research, LLC

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Bond Clinic

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Global Research Partners & Consultants, Inc.

    Calhoun, Georgia 30701
    United States

    Site Not Available

  • Decatur, Georgia
    United States

    Site Not Available

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia 30045
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center of South Georgia

    Tifton, Georgia 31794
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • Idaho Arthritis & Osteoporosis Center

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Lake County Research Associates

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Moline, Illinois
    United States

    Site Not Available

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa 52401
    United States

    Site Not Available

  • The Center for Arthritis & Osteoporosis

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • David H. Neustadt PSCq

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Gulf Coast Research

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Arthritis and Osteoporosis Center of Maryland

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Rockville, Maryland
    United States

    Site Not Available

  • The Center for Rheumatology & Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Future Care Studies

    Springfield, Massachusetts 01103
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01610
    United States

    Site Not Available

  • Justus Fiechtner, MD, MPH

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Arthritis Associates

    Hattiesburg, Mississippi 39402
    United States

    Site Not Available

  • Medical Center Healthcare Research

    Florissant, Missouri 63031
    United States

    Site Not Available

  • Medex Healthcare

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Arthritis Center of Reno

    Reno, Nevada 89502
    United States

    Site Not Available

  • Arthritis & Osteoporisis Associates

    Manalapan, New Jersey 07726
    United States

    Site Not Available

  • Rheumatology and Arthritis Associates

    Medford, New Jersey 08055
    United States

    Site Not Available

  • Voorhees, New Jersey
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Southwest Medical Associates

    Brewster, New York 10509
    United States

    Site Not Available

  • Concorde medical Group

    New York, New York
    United States

    Site Not Available

  • Rochester, New York
    United States

    Site Not Available

  • Syracuse, New York
    United States

    Site Not Available

  • Williamsville, New York
    United States

    Site Not Available

  • Arthritis Consultants of the Carolinas

    Belmont, North Carolina 28012
    United States

    Site Not Available

  • Arthritis & Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Dayton, Ohio
    United States

    Site Not Available

  • Mayfield Village, Ohio
    United States

    Site Not Available

  • Middleburg Heights, Ohio
    United States

    Site Not Available

  • Duncansville, Pennsylvania
    United States

    Site Not Available

  • Harleysville, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Orangeburg, South Carolina
    United States

    Site Not Available

  • Milan, Tennessee
    United States

    Site Not Available

  • New Tazewell, Tennessee
    United States

    Site Not Available

  • Arlington, Texas
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Carrollton, Texas
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Irving, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Sugarland, Texas
    United States

    Site Not Available

  • Ettrick, Virginia
    United States

    Site Not Available

  • Portsmouth, Virginia
    United States

    Site Not Available

  • Reston, Virginia
    United States

    Site Not Available

  • Suffolk, Virginia
    United States

    Site Not Available

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