Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

January 31, 2012 updated by: Takeda

A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Treatment duration will be 6 months.

Study Type

Interventional

Enrollment (Actual)

2269

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Hoover, Alabama, United States
      • Hueytown, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Montgomery, Alabama, United States
      • Northport, Alabama, United States
      • Ozark, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Gilbert, Arizona, United States
      • Mesa, Arizona, United States
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Sierra Vista, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Fort Smith, Arkansas, United States
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Carmichael, California, United States
      • Clovis, California, United States
      • Concord, California, United States
      • El Centro, California, United States
      • Fair Oaks, California, United States
      • Fullerton, California, United States
      • Huntington Beach, California, United States
      • Irvine, California, United States
      • LaJolla, California, United States
      • Laguna Hills, California, United States
      • Los Angeles, California, United States
      • Pasadena, California, United States
      • Rancho Cucamonga, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Luis Obispo, California, United States
      • Santa Barbara, California, United States
      • Santa Maria, California, United States
      • Torrance, California, United States
      • Tustin, California, United States
      • Vallejo, California, United States
      • Vista, California, United States
      • Walnut Creek, California, United States
      • West Covina, California, United States
      • Westlake Village, California, United States
      • Whittier, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Highlands Ranch, Colorado, United States
      • Littleton, Colorado, United States
      • Longmont, Colorado, United States
      • Wheat Ridge, Colorado, United States
    • Connecticut
      • Danbury, Connecticut, United States
      • Trumbull, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Aventura, Florida, United States
      • Boynton Beach, Florida, United States
      • Brandon, Florida, United States
      • Daytona Beach, Florida, United States
      • DeLand, Florida, United States
      • Delray Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Gainsville, Florida, United States
      • Hallandale, Florida, United States
      • Hialeah, Florida, United States
      • Holly Hill, Florida, United States
      • Jupiter, Florida, United States
      • Kissimmee, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • New Port Richey, Florida, United States
      • New Smyrna Beach, Florida, United States
      • Opa Locka, Florida, United States
      • Orlando, Florida, United States
      • South Miami, Florida, United States
      • St. Petersburg, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
      • Winter Haven, Florida, United States
      • Zephyrhills, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Conyers, Georgia, United States
      • Decatur, Georgia, United States
      • Dunwoody, Georgia, United States
      • Gainesville, Georgia, United States
      • Marietta, Georgia, United States
      • Stockbridge, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
      • Coeur d'Alene, Idaho, United States
      • Meridian, Idaho, United States
      • Nampa, Idaho, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
      • Springfield, Illinois, United States
      • Vernon Hills, Illinois, United States
    • Indiana
      • Elkhart, Indiana, United States
      • Evansville, Indiana, United States
      • Mishawaka, Indiana, United States
    • Iowa
      • Clive, Iowa, United States
      • Des Moines, Iowa, United States
      • Dubuque, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Elizabethtown, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Ruston, Louisiana, United States
      • Shreveport, Louisiana, United States
      • Slidell, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Frederick, Maryland, United States
      • Owings Mills, Maryland, United States
      • Prince Frederick, Maryland, United States
      • Wheaton, Maryland, United States
    • Massachusetts
      • Fall River, Massachusetts, United States
      • New Bedford, Massachusetts, United States
      • Springfield, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Flint, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
      • Stevensville, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Chaska, Minnesota, United States
    • Mississippi
      • Flowood, Mississippi, United States
      • Jackson, Mississippi, United States
      • Olive Branch, Mississippi, United States
    • Missouri
      • Florissant, Missouri, United States
      • Jefferson City, Missouri, United States
      • Manchester, Missouri, United States
      • Mexico, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
      • Butte, Montana, United States
    • Nebraska
      • Grand Island, Nebraska, United States
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
      • Reno, Nevada, United States
    • New Hampshire
      • Dover, New Hampshire, United States
    • New Jersey
      • Blackwood, New Jersey, United States
      • Edison, New Jersey, United States
      • Flemington, New Jersey, United States
      • Manalapan, New Jersey, United States
      • Medford, New Jersey, United States
      • Midland Park, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Endwell, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • Smithtown, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Greenville, North Carolina, United States
      • Harrisburg, North Carolina, United States
      • High Point, North Carolina, United States
      • Lenoir, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Austintown, Ohio, United States
      • Beachwood, Ohio, United States
      • Chardon, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
      • Hudson, Ohio, United States
      • Kettering, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Perrysburg, Ohio, United States
      • Toledo, Ohio, United States
      • Willoughby Hills, Ohio, United States
      • Youngstown, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Eugene, Oregon, United States
      • Lake Oswego, Oregon, United States
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • East Norriton, Pennsylvania, United States
      • Feasterville Trevose, Pennsylvania, United States
      • Harrisburg, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Mechanicsburg, Pennsylvania, United States
      • Morrisville, Pennsylvania, United States
      • Penndel, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Reading, Pennsylvania, United States
      • Scotland, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • Rhode Island
      • Cranston, Rhode Island, United States
      • East Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • Greer, South Carolina, United States
      • Mount Pleasant, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Simpsonville, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Clarksville, Tennessee, United States
      • Collierville, Tennessee, United States
      • Jackson, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
      • New Tazewell, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Bellaire, Texas, United States
      • Bryan, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Killeen, Texas, United States
      • Lake Jackson, Texas, United States
      • Odessa, Texas, United States
      • San Antonio, Texas, United States
      • Sugar Land, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Layton, Utah, United States
      • Midvale, Utah, United States
      • Salt Lake City, Utah, United States
      • St. George, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Everett, Washington, United States
      • Gig Harbor, Washington, United States
      • Lakewood, Washington, United States
      • Olympia, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
      • Vancouver, Washington, United States
    • Wisconsin
      • Monroe, Wisconsin, United States
      • Oregon, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

  • Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
  • Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
  • History of xanthinuria.
  • Alcohol consumption greater than 14/week.
  • History of significant concomitant illness.
  • Active liver or peptic ulcer disease.
  • Has rheumatoid arthritis requiring treatment.
  • Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
  • Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Febuxostat 40 mg QD
Drug: Febuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Experimental: Febuxostat 80 mg QD
Drug: Febuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Active Comparator: Allopurinol 200 mg or 300 mg QD
(dependent on renal function)
Drug: Allopurinol

Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.

Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.

Other Names:
  • Zyloprim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
Time Frame: Last Visit on treatment (up to 6 months)
The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.
Last Visit on treatment (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
Time Frame: Last Visit on treatment (up to 6 months)
The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Last Visit on treatment (up to 6 months)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Time Frame: Month 2
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.
Month 2
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Time Frame: Month 4
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.
Month 4
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Time Frame: Month 6
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Month 6
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Time Frame: Month 2
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.
Month 2
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
Time Frame: Month 4
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.
Month 4
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
Time Frame: Month 6
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.
Month 6
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
Time Frame: Last Visit on treatment (up to 6 months)
The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Last Visit on treatment (up to 6 months)
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
Time Frame: Month 2
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.
Month 2
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
Time Frame: Month 4
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.
Month 4
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
Time Frame: Month 6
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.
Month 6
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
Time Frame: Last Visit on treatment (up to 6 months)
The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Last Visit on treatment (up to 6 months)
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
Time Frame: Baseline and Month 2
Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Baseline and Month 2
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
Time Frame: Baseline and Month 4
Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Baseline and Month 4
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
Time Frame: Baseline and Month 6
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Baseline and Month 6
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
Time Frame: Baseline and Last Visit on treatment (up to 6 months)
The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Baseline and Last Visit on treatment (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-GT06-153
  • U1111-1114-0226 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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