Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

This study has been completed.

Sponsor:

Information provided by:

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT00174967

First received: September 9, 2005

Last updated: July 27, 2011

Last verified: July 2011

History of Changes

Results First Received: March 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
Condition:	Gout
Interventions:	Drug: Placebo Drug: Febuxostat

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups. All other subjects also initiated prophylactic medications.

Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily.
Placebo QD	Placebo, orally, once daily

Participant Flow: Overall Study

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
STARTED	37	40	38	38
COMPLETED	36	37	36	36
NOT COMPLETED	1	3	2	2
Adverse Event	1	2	2	1
Gout Flare	0	0	0	1
Not Specified	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily.
Placebo QD	Placebo, orally, once daily
Total	Total of all reporting groups

Baseline Measures

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
Number of Participants [units: participants]	37	40	38	38	153
Age [units: years] Mean ± Standard Deviation	52.2 ± 14.04	55.2 ± 13.09	56.2 ± 10.83	52.4 ± 12.63	54.0 ± 12.69
Age, Customized [units: participants]
<45 years	8	10	7	12	37
45 years to <65 years	21	19	23	17	80
≥65 years	8	11	8	9	36
Gender [units: participants]
Female	4	2	5	6	17
Male	33	38	33	32	136
Race/Ethnicity, Customized [units: participants]
White	32	35	34	32	133
Black or African American	3	3	2	3	11
Hispanic	1	1	1	1	4
Asian	0	1	1	0	2
Other	1	0	0	2	3
Body Mass Index [units: participants]
≤25 kilogram per meter² (kg/m²)	2	3	3	0	8
>25 kg/m² to 30 kg/m²	12	12	14	13	51
>30 kg/m² to 35 kg/m²	16	12	12	16	56
>35 kg/m² to 40 kg/m²	4	7	5	6	22
>40 kg/m²	3	6	3	3	15
missing	0	0	1	0	1

Outcome Measures

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1. Primary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. [ Time Frame: Day 28. ]

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2. Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. [ Time Frame: Day 7. ]

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3. Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. [ Time Frame: Day 14. ]

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4. Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. [ Time Frame: Day 21. ]

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5. Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. [ Time Frame: Baseline and Day 7. ]

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6. Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. [ Time Frame: Baseline and Day 14. ]

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7. Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit [ Time Frame: Baseline and Day 21. ]

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8. Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. [ Time Frame: Baseline and Day 28. ]

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9. Secondary:

Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. [ Time Frame: Baseline and Any visit (Day 7, 14, 21,or 28) ]

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10. Secondary:

Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. [ Time Frame: Baseline and Day 28. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research & Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

Publications of Results:

Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23.

Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. Epub 2006 Aug 15.

Goldfarb DS, Macdonald PA, Hunt B, Gunawardhana L. Febuxostat in gout: serum urate response in uric Acid overproducers and underexcretors. J Rheumatol. 2011 Jul;38(7):1385-9. Epub 2011 May 15.

Responsible Party:	Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174967 History of Changes
Other Study ID Numbers:	TMX-00-004, U1111-1114-1992
Study First Received:	September 9, 2005
Results First Received:	March 12, 2009
Last Updated:	July 27, 2011
Health Authority:	United States: Food and Drug Administration

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