Safety and Efficacy of Oral Febuxostat in Subjects With Gout

This study has been completed.
Sponsor:
Collaborator:
Qingdao Shengbang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT02082769
First received: March 6, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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


Condition Intervention Phase
Gout
Drug: Febuxostat
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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 28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082769

Sponsors and Collaborators
Xijing Hospital
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. Qingdao University
Principal Investigator: Xiumei Liu, M.D. The First Hospital of Shanxi Medical University
Principal Investigator: Hong Liu, M.D. Guangxi Medical University
Principal Investigator: Yongde Peng, M.D. Shanghai First People's Hospital
Principal Investigator: Jianqin Wang, M.D. LanZhou University
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. First Hospital of Jilin University
Principal Investigator: Ying Lu, M.D. Zhejiang Provincial Tongde Hospital
Principal Investigator: Peng Liu, M.D. Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Principal Investigator: Yonghong Zhang, M.D. Luoyang Orthopedic-Traumatological Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02082769     History of Changes
Other Study ID Numbers: SFDA2010L04287
Study First Received: March 6, 2014
Last Updated: March 6, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Gout
Uric Acid
Xanthine oxidase
Febuxostat

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014