NCT00174967

Brief Summary

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2001

Shorter than P25 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

January 1, 2001

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 16, 2009

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

September 9, 2005

Results QC Date

March 12, 2009

Last Update Submit

July 27, 2011

Conditions

Gout

Keywords

Uric Acidxanthine oxidasetophiDrug Therapy

Outcome Measures

Primary Outcomes (1)

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

    Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.

    Day 28.

Secondary Outcomes (9)

  • Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.

    Day 7.

  • Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.

    Day 14.

  • Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.

    Day 21.

  • Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.

    Baseline and Day 7.

  • Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.

    Baseline and Day 14.

  • +4 more secondary outcomes

Study Arms (4)

Placebo QD

PLACEBO COMPARATOR
Drug: Placebo

Febuxostat 40 mg QD

EXPERIMENTAL
Drug: Febuxostat

Febuxostat 80 mg QD

EXPERIMENTAL
Drug: Febuxostat

Febuxostat 120 mg QD

EXPERIMENTAL
Drug: Febuxostat

Interventions

PlaceboDRUG

Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.

Placebo QD
FebuxostatDRUG

Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.

Also known as: TMX-67, Tei-6720, Uloric
Febuxostat 40 mg QD

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).
  • Must meet American College of Rheumatology criteria for gout.
  • Must have adequate renal function (serum creatinine \<1.5 mg/dL).
  • 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 kilogram per meter² (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)

  • 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. doi: 10.1002/art.20935.

    PMID: 15751090RESULT

  • 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

  • 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. doi: 10.3899/jrheum.101156. Epub 2011 May 15.

    PMID: 21572152RESULT

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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

January 1, 2001

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

July 29, 2011

Results First Posted

July 16, 2009

Record last verified: 2011-07