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Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Primary Purpose

Gout

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Febuxostat

Allopurinol

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout, Uric Acid, Xanthine oxidase, Febuxostat

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Febuxostat 40 mg QD

Febuxostat 80 mg QD

Allopurinol 100mg QD

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02082769

First Posted

March 6, 2014

Last Updated

December 30, 2015

Sponsor

Xijing Hospital

Collaborators

Qingdao Shengbang Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02082769

Brief Title

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

Collaborators

Qingdao Shengbang Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout

Keywords

Gout, Uric Acid, Xanthine oxidase, Febuxostat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

504 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Febuxostat 40 mg QD

Arm Type

Experimental

Arm Description

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

Arm Title

Febuxostat 80 mg QD

Arm Type

Experimental

Arm Description

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

Arm Title

Allopurinol 100mg QD

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Febuxostat

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

Final Visit (up to 26 weeks)

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Baseline and Final Visit (up to 26 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: