Safety and Efficacy of Oral Febuxostat in Subjects With Gout

NCT02082769 | Completed Phase 3 Results DMC

• 1 other identifier: SFDA2010L04287
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gout

Keywords

Gout; Uric Acid; Xanthine oxidase; Febuxostat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Final Visit (up to 26 weeks)

Other Outcomes (1)

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

  Baseline and Final Visit (up to 26 weeks)

Study Arms (3)

Febuxostat 40 mg QD

EXPERIMENTAL

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Drug: Febuxostat

Febuxostat 80 mg QD

EXPERIMENTAL

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Drug: Febuxostat

Allopurinol 100mg QD

ACTIVE COMPARATOR

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Drug: Allopurinol

Interventions

Febuxostat DRUG

Febuxostat 40 mg QD; Febuxostat 80 mg QD

Allopurinol DRUG

Allopurinol 100mg QD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Qingdao Shengbang Pharmaceutical Co., Ltd.: collaborator

Related Publications (1)

• 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.

  PMID: 26013187 DERIVED

MeSH Terms

Conditions

Gout

Interventions

Febuxostat; Allopurinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Qiuhe Ji
• Organization: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

qiuheji@hotmail.com

+86-29-84775213

Study Officials

• Shenren Chen, M.D.

  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 Zhuang Autonomous Region

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2014-03