AzTrials
AzTrials

GoutPhase 3CONFIRMSNCT00430248

Efficacy and Safety of Oral Febuxostat in Participants With Gout

A Phase 3 study testing Febuxostat and Allopurinol in people with Gout, run by Takeda at 258 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

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout
What is being tested?
Febuxostat and Allopurinol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,269 participants
Where
258 sitesUnited States
Study dates
Feb 2007to Mar 2008
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

258 sites in 1 country.

258 sites in 1 country

United States258 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Austintown, Ohio

  • Study site

    Aventura, Florida

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beachwood, Ohio

  • Study site

    Beaumont, Texas

  • Study site

    Bellaire, Texas

  • Study site

    Bend, Oregon

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Blackwood, New Jersey

  • Study site

    Boise, Idaho

  • Study site

    Boulder, Colorado

  • Study site

    Boynton Beach, Florida

  • Study site

    Brandon, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Bryan, Texas

  • Study site

    Butte, Montana

  • Study site

    Carmichael, California

  • Study site

    Chandler, Arizona

  • Study site

    Chardon, Ohio

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chaska, Minnesota

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksville, Tennessee

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Clovis, California

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Collierville, Tennessee

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Concord, California

  • Study site

    Conyers, Georgia

  • Study site

    Cranston, Rhode Island

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Decatur, Georgia

  • Study site

    DeLand, Florida

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Dover, New Hampshire

  • Study site

    Dubuque, Iowa

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Dunwoody, Georgia

  • Study site

    East Norriton, Pennsylvania

  • Study site

    East Providence, Rhode Island

  • Study site

    Edison, New Jersey

  • Study site

    El Centro, California

  • Study site

    El Paso, Texas

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Elkhart, Indiana

  • Study site

    Endwell, New York

  • Study site

    Eugene, Oregon

  • Study site

    Evanston, Illinois

  • Study site

    Evansville, Indiana

  • Study site

    Everett, Washington

  • Study site

    Fair Oaks, California

  • Study site

    Fall River, Massachusetts

  • Study site

    Feasterville-Trevose, Pennsylvania

  • Study site

    Flemington, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Florissant, Missouri

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Worth, Texas

  • Study site

    Frederick, Maryland

  • Study site

    Fullerton, California

  • Study site

    Gainesville, Georgia

  • Study site

    Gainsville, Florida

  • Study site

    Gig Harbor, Washington

  • Study site

    Gilbert, Arizona

  • Study site

    Grand Island, Nebraska

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hallandale, Florida

  • Study site

    Harrisburg, North Carolina

  • Study site

    Harrisburg, Pennsylvania

  • Study site

    Hialeah, Florida

  • Study site

    High Point, North Carolina

  • Study site

    Highlands Ranch, Colorado

  • Study site

    Holly Hill, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Hoover, Alabama

  • Study site

    Houston, Texas

  • Study site

    Hudson, Ohio

  • Study site

    Hueytown, Alabama

  • Study site

    Huntington Beach, California

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Jackson, Mississippi

  • Study site

    Jackson, Tennessee

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Jonesboro, Arkansas

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Kansas

  • Study site

    Kettering, Ohio

  • Study site

    Killeen, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    La Jolla, California

  • Study site

    Laguna Hills, California

  • Study site

    Lake Jackson, Texas

  • Study site

    Lake Oswego, Oregon

  • Study site

    Lakewood, Washington

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Layton, Utah

  • Study site

    Lenoir, North Carolina

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Longmont, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lyndhurst, Ohio

  • Study site

    Manalapan, New Jersey

  • Study site

    Manchester, Missouri

  • Study site

    Marietta, Georgia

  • Study site

    Mechanicsburg, Pennsylvania

  • Study site

    Medford, New Jersey

  • Study site

    Medford, Oregon

  • Study site

    Memphis, Tennessee

  • Study site

    Meridian, Idaho

  • Study site

    Mesa, Arizona

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Miami, Florida

  • Study site

    Midland Park, New Jersey

  • Study site

    Midvale, Utah

  • Study site

    Mineola, New York

  • Study site

    Mishawaka, Indiana

  • Study site

    Mobile, Alabama

  • Study site

    Monroe, Wisconsin

  • Study site

    Montgomery, Alabama

  • Study site

    Morrisville, Pennsylvania

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Nampa, Idaho

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Bedford, Massachusetts

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    New Smyrna Beach, Florida

  • Study site

    New Tazewell, Tennessee

  • Study site

    New York, New York

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • Study site

    Northport, Alabama

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Olympia, Washington

  • Study site

    Omaha, Nebraska

  • Study site

    Opa-locka, Florida

  • Study site

    Orangeburg, South Carolina

  • Study site

    Oregon, Wisconsin

  • Study site

    Orlando, Florida

  • Study site

    Owings Mills, Maryland

  • Study site

    Ozark, Alabama

  • Study site

    Pasadena, California

  • Study site

    Penndel, Pennsylvania

  • Study site

    Peoria, Arizona

  • Study site

    Perrysburg, Ohio

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Cucamonga, California

  • Study site

    Reading, Pennsylvania

  • Study site

    Reno, Nevada

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Ruston, Louisiana

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Luis Obispo, California

  • Study site

    Santa Barbara, California

  • Study site

    Santa Maria, California

  • Study site

    Scotland, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Shreveport, Louisiana

  • Study site

    Sierra Vista, Arizona

  • Study site

    Simpsonville, South Carolina

  • Study site

    Slidell, Louisiana

  • Study site

    Smithtown, New York

  • Study site

    South Miami, Florida

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Massachusetts

  • Study site

    St Louis, Missouri

  • Study site

    St. George, Utah

  • Study site

    St. Petersburg, Florida

  • Study site

    Stevensville, Michigan

  • Study site

    Stockbridge, Georgia

  • Study site

    Sugar Land, Texas

  • Study site

    Syracuse, New York

  • Study site

    Tacoma, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Troy, Michigan

  • Study site

    Trumbull, Connecticut

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Tustin, California

  • Study site

    Vallejo, California

  • Study site

    Vancouver, Washington

  • Study site

    Vernon Hills, Illinois

  • Study site

    Vista, California

  • Study site

    Waco, Texas

  • Study site

    Walnut Creek, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Covina, California

  • Study site

    West Jordan, Utah

  • Study site

    West Palm Beach, Florida

  • Study site

    West Reading, Pennsylvania

  • Study site

    Westlake Village, California

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wheaton, Maryland

  • Study site

    Whittier, California

  • Study site

    Wichita, Kansas

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    Youngstown, Ohio

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Gout
Being tested
Febuxostat, Allopurinol
Keywords
tophi, hyperuricemia, uric acid, Drug Therapy
Medical subject headings
Gout, Hyperuricemia

What participants receive

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

  • FebuxostatDrug

    Also called TMX-67, Tei-6720, Uloric

    Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.

  • FebuxostatDrug

    Also called TMX-67, Tei-6720, Uloric

    Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.

  • AllopurinolDrug

    Also called Zyloprim

    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.

Study groups in NCT00430248
Study groupRoleWhat they receive
Febuxostat 40 mg QDExperimentalNot described
Receives: Drug: Febuxostat
Febuxostat 80 mg QDExperimentalNot described
Receives: Drug: Febuxostat
Allopurinol 200 mg or 300 mg QDActive comparator(dependent on renal function)
Receives: Drug: Allopurinol

What is being measured

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

  1. Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.

    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.

    Measured: Last Visit on treatment (up to 6 months)

Secondary outcomes (16)

  1. Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl

    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.

    Measured: Last Visit on treatment (up to 6 months)

  2. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.

    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.

    Measured: Month 2

  3. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.

    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.

    Measured: Month 4

  4. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.

    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.

    Measured: Month 6

  5. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.

    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.

    Measured: Month 2

  6. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.

    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.

    Measured: Month 4

  7. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.

    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.

    Measured: Month 6

  8. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.

    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.

    Measured: Last Visit on treatment (up to 6 months)

  9. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit

    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.

    Measured: Month 2

  10. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit

    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.

    Measured: Month 4

  11. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit

    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.

    Measured: Month 6

  12. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit

    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.

    Measured: Last Visit on treatment (up to 6 months)

  13. Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.

    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.

    Measured: Baseline and Month 2

  14. Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit

    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.

    Measured: Baseline and Month 4

  15. Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.

    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.

    Measured: Baseline and Month 6

  16. Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.

    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.

    Measured: Baseline and Last Visit on treatment (up to 6 months)

Timeline

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

  1. First posted1 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionMar 2008
  4. Study completionMar 2008

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430248
Sponsor's protocol ID
F-GT06-153
Other IDs
U1111-1114-0226
Acronym
CONFIRMS
Status last verified
Jan 2012
First submitted
25 Jan 2007
Last updated
2 Feb 2012
Data monitoring committee
Yes

Publications

  • Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.

    PubMed 20370912

  • Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.

    PubMed 21353107

  • Becker MA, MacDonald PA, Hunt B, Gunawardhana L. Treating hyperuricemia of gout: safety and efficacy of febuxostat and allopurinol in older versus younger subjects. Nucleosides Nucleotides Nucleic Acids. 2011 Dec;30(12):1011-7. doi: 10.1080/15257770.2011.603715.

    PubMed 22132950

  • Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.

    PubMed 22052584

  • Becker MA, MacDonald PA, Hunt BJ, Jackson RL. Diabetes and gout: efficacy and safety of febuxostat and allopurinol. Diabetes Obes Metab. 2013 Nov;15(11):1049-55. doi: 10.1111/dom.12135. Epub 2013 Jun 12.

    PubMed 23683134

  • Jackson RL, Hunt B, MacDonald PA. The efficacy and safety of febuxostat for urate lowering in gout patients >/=65 years of age. BMC Geriatr. 2012 Mar 21;12:11. doi: 10.1186/1471-2318-12-11.

    PubMed 22436129

  • Wells AF, MacDonald PA, Chefo S, Jackson RL. African American patients with gout: efficacy and safety of febuxostat vs allopurinol. BMC Musculoskelet Disord. 2012 Feb 9;13:15. doi: 10.1186/1471-2474-13-15.

    PubMed 22316106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Febuxostat and Allopurinol in people with Gout, run by Takeda at 258 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 3 inclusion and 9 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 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. 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 16 Jul 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?

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)). 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 NCT00430248, which also lists 7 linked publications.

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 2 Feb 2012.

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