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Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)
This study has been completed.
Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00430248
First received: January 25, 2007
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Gout | Drug: Febuxostat Drug: Allopurinol | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout. |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
| Enrollment: | 2269 |
| Study Start Date: | February 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Febuxostat 40 mg QD |
Drug: Febuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Other Names:
|
| Experimental: Febuxostat 80 mg QD |
Drug: Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Other Names:
|
|
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 Name: Zyloprim
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00430248
Show 258 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430248
Show 258 Study Locations
Sponsors and Collaborators
Takeda
Investigators
| Study Chair: | Medical Director | Takeda |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT00430248 History of Changes |
| Other Study ID Numbers: |
F-GT06-153 U1111-1114-0226 ( Registry Identifier: WHO ) |
| Study First Received: | January 25, 2007 |
| Results First Received: | March 12, 2009 |
| Last Updated: | January 31, 2012 |
Keywords provided by Takeda:
|
tophi hyperuricemia uric acid Drug Therapy |
Additional relevant MeSH terms:
|
Gout Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Allopurinol |
Febuxostat Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Gout Suppressants Antirheumatic Agents Free Radical Scavengers Antioxidants Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 28, 2017