NCT00174941

Brief Summary

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 16, 2009

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

5.8 years

First QC Date

September 12, 2005

Results QC Date

March 12, 2009

Last Update Submit

January 25, 2011

Conditions

Gout

Keywords

Uric acidxanthine oxidasetophiDrug Therapy

Outcome Measures

Primary Outcomes (8)

  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <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

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

    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 or is Maintained at <6.0 mg/dL at Month 18 Visit.

    Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized.

    Month 18

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

    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 or is Maintained at <6.0 mg/dL at Month 36 Visit.

    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 or is Maintained at <6.0 mg/dL at Month 48 Visit.

    Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized.

    Month 48

  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.

    Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized.

    Month 60

  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.

    The percentage of subjects 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 66 months).

Secondary Outcomes (8)

  • Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.

    Baseline and Month 6

  • Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.

    Baseline and Month 12

  • Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.

    Baseline and Month 18

  • Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.

    Baseline and Month 24

  • Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.

    Baseline and Month 36

  • +3 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL
Drug: Febuxostat

2

EXPERIMENTAL
Drug: Febuxostat

3

EXPERIMENTAL
Drug: Febuxostat

Interventions

FebuxostatDRUG

Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.

Also known as: TMX-67, Tei-6720, Uloric
1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
  • Must meet American College of Rheumatology criteria for gout.
  • Must have adequate renal function (serum creatinine \<1.5 mg/dL).
  • Must have completed four weeks of double-blind dosing in Study TMX-00-004.
  • Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.
  • 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:

  • History of xanthinuria
  • Alcohol consumption \>14/week
  • Has a History of significant concomitant illness
  • Has active liver disease.
  • Has a body mass index greater than 50 kg/m2
  • Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.

    PMID: 16911575RESULT

  • Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457.

    PMID: 19141576RESULT

  • Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4.

    PMID: 21169856RESULT

Related Links

MeSH Terms

Conditions

Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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 CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON 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

March 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 27, 2011

Results First Posted

July 16, 2009

Record last verified: 2011-01