Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082769
• Other study ID #: SFDA2010L04287
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2014
• Last updated: December 30, 2015
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Febuxostat

• Allopurinol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Qingdao Shengbang Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline		Baseline and Final Visit (up to 26 weeks)	No
Primary	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)	No
Secondary	Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit		Final Visit (up to 26 weeks)	No