Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

NCT00102440 | Completed Phase 3 Results

• 2 other identifiers: C02-010U1111-1114-0184
• Study Type: interventional
• Target: 760
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

Conditions

Gout

Keywords

uric Acid; xanthine oxidase; tophi; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)

  Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.

  Last 3 Visits (up to 52 weeks)

Secondary Outcomes (13)

• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit

  Week 28

• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit

  Week 52

• Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit

  Final Visit (up to 52 weeks)

• Percent Change From Baseline in Serum Urate Levels at Week 28.

  Baseline and Week 28

• Percent Change From Baseline in Serum Urate Levels at Week 52.

  Baseline and Week 52

Study Arms (3)

Febuxostat 80 mg QD

EXPERIMENTAL

Drug: Febuxostat

Febuxostat 120 mg QD

EXPERIMENTAL

Drug: Febuxostat

Allopurinol 300 mg QD

ACTIVE COMPARATOR

Drug: Allopurinol

Interventions

Febuxostat DRUG

Febuxostat 80 mg, orally, once daily for up to 52 weeks.

Also known as: TMX-67, Tei-6720, Uloric

Febuxostat 80 mg QD

Allopurinol DRUG

Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Allopurinol 300 mg QD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
• Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

You may not qualify if:

• Serum creatinine \>1.5 mg/dL
• Calculated creatinine clearance of \<50 milliliters per minutes (mL/min)
• Pregnancy or lactation;
• Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates;
• Body Mass Index (BMI) \>50 kilogram per meter²(kg/m²);
• A history of xanthinuria, active liver disease, or hepatic dysfunction;
• A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.

Sponsors & Collaborators

• Takeda: lead

Related Publications (4)

• Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.

  PMID: 16339094 RESULT

• Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.

  PMID: 18600509 RESULT

• 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.

  PMID: 21353107 RESULT

• 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.

  PMID: 22052584 RESULT

Related Links

• American College of Rheumatology
• Uloric Package Insert

MeSH Terms

Conditions

Gout

Interventions

Febuxostat; Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research & Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2005
• First Posted: January 31, 2005
• Study Start: July 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: February 2, 2012
• Results First Posted: July 16, 2009

Record last verified: 2012-01