Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

NCT00175019 | Completed Phase 3 Results

• 2 other identifiers: C02-021U1111-1113-9814
• Study Type: interventional
• Target: 1,086
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.

Conditions

Gout

Keywords

uric acid; xanthine oxidase; hyperuricemia; tophi; Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.

  Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 1 visit was summarized.

  Month 1

• Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.

  Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized.

  Month 12

• Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.

  Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized.

  Month 24

• Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.

  Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized.

  Month 36

• Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.

  The percentage of subjects whose serum urate was \<6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.

  Last Visit on treatment (up to 40 months).

Secondary Outcomes (8)

• Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.

  Last Visit on treatment (up to 40 months).

• Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.

  Month 12

• Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.

  Month 24

• Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.

  Month 36

• Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.

  Final Visit (up to 40 months).

Study Arms (3)

Febuxostat 80 mg QD

EXPERIMENTAL

Drug: Febuxostat

Febuxostat 120 mg QD

EXPERIMENTAL

Drug: Febuxostat

Allopurinol QD

ACTIVE COMPARATOR

Drug: Allopurinol

Interventions

Febuxostat DRUG

Febuxostat 80 mg, tablets, orally, once daily.

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

Febuxostat 80 mg QD

Allopurinol DRUG

Allopurinol 100 mg or 300 mg, tablets, orally, once daily.

Also known as: Zyloprim

Allopurinol 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:

• Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
• Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
• Has participated in a clinical study in which febuxostat was administered.
• Is completing Phase 3 Studies C02-009 or C02-010.
• Must not have experienced any serious study drug-related adverse events in the previous study.
• 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

You may not qualify if:

• Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
• Is intolerant of allopurinol.

Sponsors & Collaborators

• Takeda: lead

Related Publications (1)

• Becker MA, Schumacher HR, MacDonald PA, Lloyd E, Lademacher C. Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout. J Rheumatol. 2009 Jun;36(6):1273-82. doi: 10.3899/jrheum.080814. Epub 2009 Mar 13.

  PMID: 19286847 RESULT

Related Links

• Uloric Package Insert

MeSH Terms

Conditions

Gout; Hyperuricemia

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Subjects may receive \>1 treatment. Adverse events are summarized by treatment at time of observation and subjects who receive \>1 treatment are summarized for each treatment they receive, so subjects at risk will not match number of participants.

Results Point of Contact

• Title: Senior Vice President, Clinical Science
• Organization: Takeda Global Research & Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director

  Takeda

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: July 27, 2010
• Results First Posted: September 7, 2009

Record last verified: 2010-07