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

July 27, 2011 updated by: Takeda

Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo QD
Drug: Placebo
Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
Experimental: Febuxostat 40 mg QD
Drug: Febuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Experimental: Febuxostat 80 mg QD
Drug: Febuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Experimental: Febuxostat 120 mg QD
Drug: Febuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720
Drug: Febuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Other Names:
  • Uloric
  • TMX-67
  • Tei-6720

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.
Time Frame: Day 7.
Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.
Day 7.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.
Time Frame: Day 14.
Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.
Day 14.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.
Time Frame: Day 21.
Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.
Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.
Time Frame: Baseline and Day 7.
Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.
Baseline and Day 7.
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.
Time Frame: Baseline and Day 14.
Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.
Baseline and Day 14.
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit
Time Frame: Baseline and Day 21.
Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.
Baseline and Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.
Time Frame: Baseline and Day 28.
Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.
Baseline and Day 28.
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)
Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.
Baseline and Any visit (Day 7, 14, 21,or 28)
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.
Time Frame: Baseline and Day 28.
24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.
Baseline and Day 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

July 1, 2001

Study Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMX-00-004
  • U1111-1114-1992 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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