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GoutPhase 3AGREENCT00506883

MPC-004 for the Treatment of an Acute Gout Flare

A Phase 3 study testing High Dose Colchicine (4.8 mg total dose) and Low Dose Colchicine (1.8mg total dose) in people with Gout, run by Takeda at 83 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gout
What is being tested?
High Dose Colchicine (4.8 mg total dose) and Low Dose Colchicine (1.8mg total dose)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
83 sitesUnited States
Study dates
Apr 2007to Oct 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

83 sites in 1 country.

83 sites in 1 country

United States83 sites

  • Study site

    Albany, New York

  • Study site

    Arlington, Texas

  • Study site

    Austin, Texas

  • Gulf Coast Research

    Baton Rouge, Louisiana, 70808

  • Arthritis Consultants of the Carolinas

    Belmont, North Carolina, 28012

  • Innovative Clinical Trials

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Southwest Medical Associates

    Brewster, New York, 10509

  • Global Research Partners & Consultants, Inc.

    Calhoun, Georgia, 30701

  • Study site

    Carrollton, Texas

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa, 52401

  • Arthritis & Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina, 28207

  • Florida Medical Center

    Clearwater, Florida, 33755

  • Tomac, Inc.

    Columbiana, Alabama, 35051

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • Study site

    Dayton, Ohio

  • Study site

    Decatur, Georgia

  • Study site

    Duncansville, Pennsylvania

  • The Center for Arthritis & Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Study site

    Ettrick, Virginia

  • Medical Center Healthcare Research

    Florissant, Missouri, 63031

  • Study site

    Fort Worth, Texas

  • Arthritis and Osteoporosis Center of Maryland

    Frederick, Maryland, 21702

  • Southeastern Integrated Medical

    Gainesville, Florida, 32607

  • George E. Platt, MD

    Green Cove Springs, Florida, 32043

  • Study site

    Harleysville, Pennsylvania

  • Arthritis Associates

    Hattiesburg, Mississippi, 39402

  • Study site

    Houston, Texas

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • Irvine Center for Clinical Research

    Irvine, California, 92618

  • Study site

    Irving, Texas

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • NEA Clinic

    Jonesboro, Arkansas, 72401

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Study site

    La Jolla, California

  • Study site

    Lake Mary, Florida

  • Medical Research Trust

    Lake Worth, Florida, 33461

  • Justus Fiechtner, MD, MPH

    Lansing, Michigan, 48910

  • Study site

    Las Vegas, Nevada

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia, 30045

  • Lake County Research Associates

    Libertyville, Illinois, 60048

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas, 72204

  • David H. Neustadt PSCq

    Louisville, Kentucky, 40202

  • Arthritis & Osteoporisis Associates

    Manalapan, New Jersey, 07726

  • Study site

    Mayfield Village, Ohio

  • Rheumatology and Arthritis Associates

    Medford, New Jersey, 08055

  • Idaho Arthritis & Osteoporosis Center

    Meridian, Idaho, 83642

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Milan, Tennessee

  • Study site

    Moline, Illinois

  • Study site

    New Tazewell, Tennessee

  • Concorde medical Group

    New York, New York

  • Hillcrest Medical Center

    Orange City, Florida, 32763

  • Study site

    Orangeburg, South Carolina

  • Farmer MD, PA

    Ormond Beach, Florida, 32174

  • Study site

    Paramount, California

  • Study site

    Philadelphia, Pennsylvania

  • Coastal Medical Research, Inc.

    Port Orange, Florida, 32127

  • Study site

    Portsmouth, Virginia

  • Rancho Cucamonga Clinical Trials

    Rancho Cucamonga, California, 91730

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • Study site

    Reston, Virginia

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Future Care Studies

    Springfield, Massachusetts, 01103

  • Medex Healthcare

    St Louis, Missouri, 63117

  • Study site

    Suffolk, Virginia

  • Study site

    Sugarland, Texas

  • Study site

    Syracuse, New York

  • Southwest Florida Clinical Research Center

    Tampa, Florida, 33609

  • Arthritis & Osteoporosis Center of South Georgia

    Tifton, Georgia, 31794

  • Genova Clinical Research

    Tucson, Arizona, 85741

  • Study site

    Tucson, Arizona

  • Geodessey Research, LLC

    Vero Beach, Florida, 32960

  • Study site

    Voorhees Township, New Jersey

  • Study site

    West Covina, California

  • The Center for Rheumatology & Bone Research

    Wheaton, Maryland, 20902

  • Study site

    Williamsville, New York

  • Bond Clinic

    Winter Haven, Florida, 33880

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: 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

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.

Read the detailed 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.

Conditions
Gout
Being tested
High Dose Colchicine (4.8 mg total dose), Low Dose Colchicine (1.8mg total dose), Placebo Control
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose Colchicine (4.8 mg total dose)Drug

    Also called Colcrys TM, Colchicine 0.6 mg

    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)Drug

    Also called Colcrys TM, Colchicine 0.6 mg

    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 ControlOther

    Also called Placebo capsule

    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.

Study groups in NCT00506883
Study groupRoleWhat they receive
High Dose ColchicineExperimentalAfter 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).
Receives: Drug: High Dose Colchicine (4.8 mg total dose)
Low Dose ColchicineExperimentalWithin 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
Receives: Drug: Low Dose Colchicine (1.8mg total dose)
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00506883
Sponsor's protocol ID
MPC 004-06-3001
Acronym
AGREE
Status last verified
Oct 2012
First submitted
23 Jul 2007
Last updated
1 Nov 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 20131255

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High Dose Colchicine (4.8 mg total dose) and Low Dose Colchicine (1.8mg total dose) in people with Gout, run by Takeda at 83 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responders (time frame: 24 hours after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00506883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.

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