Efficacy and Safety of Oral Febuxostat in Participants With Gout

Gout Clinical Trial

— CONFIRMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430248
• Other study ID #: F-GT06-153
• Secondary ID: U1111-1114-0226
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2007
• Last updated: January 31, 2012
• Start date: February 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2269
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Febuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
• Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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/a — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Last Visit on treatment (up to 6 months)	No
Secondary	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.	Last Visit on treatment (up to 6 months)	No
Secondary	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.	Month 2	No
Secondary	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.	Month 4	No
Secondary	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.	Month 6	No
Secondary	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.	Month 2	No
Secondary	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.	Month 4	No
Secondary	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.	Month 6	No
Secondary	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.	Last Visit on treatment (up to 6 months)	No
Secondary	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.	Month 2	No
Secondary	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.	Month 4	No
Secondary	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.	Month 6	No
Secondary	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.	Last Visit on treatment (up to 6 months)	No
Secondary	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.	Baseline and Month 2	No
Secondary	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.	Baseline and Month 4	No
Secondary	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.	Baseline and Month 6	No
Secondary	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.	Baseline and Last Visit on treatment (up to 6 months)	No

External Links

•   FDA Safety Alerts and Recalls
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