Safety and Efficacy of Oral Febuxostat in Subjects With Gout

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

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

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Allopurinol; Drug: Febuxostat

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Febuxostat 40 mg QD; Febuxostat 40 mg, orally, once daily for up to 24 weeks	Drug: Febuxostat
Experimental: Febuxostat 80 mg QD; Febuxostat 80 mg, orally, once daily for up to 24 weeks	Drug: Febuxostat
Active Comparator: Allopurinol 100mg QD; Allopurinol 100mg, orally, three times daily for up to 24 weeks	Drug: Allopurinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Last 3 visits (any last 3 visits up to week 26)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Final Visit (up to 26 weeks)

Other Outcome Measures

Outcome Measure	Time Frame
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Baseline and Final Visit (up to 26 weeks)

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Qingdao Shengbang Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Shenren Chen, M.D., The Second Affiliated Hospital of Shantou University Medical College; Principal Investigator: Yangang Wang, M.D., The Affiliated Hospital of Qingdao University; Principal Investigator: Xiumei Liu, M.D., The First Affiliated Hospital of Shanxi Medical University; Principal Investigator: Hong Liu, M.D., First Affiliated Hospital of Guangxi Medical University; Principal Investigator: Yongde Peng, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Jianqin Wang, M.D., Lanzhou University Second Hospital; Principal Investigator: Jinying Lin, M.D., People's Hospital of Guangxi; Principal Investigator: Haiwang Ji, M.D., Shaanxi Provincial People's Hospital; Principal Investigator: Bin Liu, M.D., The First Hospital of Jilin University; Principal Investigator: Ying Lu, M.D., Zhejiang Provincial Tongde Hospital; Principal Investigator: Peng Liu, M.D., Guangxi Ruikang Hospital; Principal Investigator: Yonghong Zhang, M.D., Luoyang Orthopedic-Traumatological Hospital

Publications and helpful links

General Publications

• Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Gout; Febuxostat; Uric Acid; Xanthine oxidase
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol; Febuxostat
• Other Study ID Numbers: SFDA2010L04287