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Completed

NCT Number: NCT02082769

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
  • Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
  • No gout flare 2 weeks beforehand during 2-week screening period.

Exclusion criteria

  • Pregnancy or lactation;
  • Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
  • Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
  • A history of active liver disease, or hepatic dysfunction;
  • A history of bronchial asthma;
  • A history of renal calculi or thyroid disease;
  • Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
  • Intolerance to allopurinol and Ibuprofen;
  • Alcohol intake of ≥ 14 drinks/week;
  • Clinically significant medical condition.

Treatment and study plan

Febuxostat

Drug

Allopurinol

Drug

Primary outcomes

  1. Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)

    Time frame: Last 3 visits (any last 3 visits up to week 26)

Secondary outcomes

  1. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit

    Time frame: Final Visit (up to 26 weeks)

Other outcomes

  1. Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline

    Time frame: Baseline and Final Visit (up to 26 weeks)

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • Qingdao Shengbang Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 10, 2014
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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