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Phase III Trial of Febuxostat in Korea Gout Patients

Primary Purpose

Gout

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Febuxostat

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age :18-85 years
female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
female: negative serum pregnancy test
subjects who satisfy ARA (American Rheumatism Association)
subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1>

1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria

Exclusion Criteria:

women who are breast-feeding or pregnant
a history of xanthinuria
allopurinol intolerance
receiving thiazide diuretic therapy
secondary hyperuricemia
required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).
any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
concomitant therapy with any urate-lowering therapy
active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
subject was unable to take colchicine or contradictory to colchicine
a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy
rheumatoid arthritis or any active arthritis requiring for the medication treatment
a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
participated in another investigational trial within the 30days prior to the screening visit
any other significant medical condition as defined by the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

1 Febuxostat 40mg

2 Febuxostat 80mg

3 Febuxostat 120mg

4 Allopurinol 300mg

5 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00821392

First Posted

January 12, 2009

Last Updated

January 12, 2009

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00821392

Brief Title

Phase III Trial of Febuxostat in Korea Gout Patients

Official Title

A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

Detailed Description

This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration. If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

6. Conditions and Keywords

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

Gout

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Febuxostat 40mg

Arm Type

Active Comparator

Arm Title

2 Febuxostat 80mg

Arm Type

Active Comparator

Arm Title

3 Febuxostat 120mg

Arm Type

Active Comparator

Arm Title

4 Allopurinol 300mg

Arm Type

Sham Comparator

Arm Title

5 Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Febuxostat

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: <Day -14> age :18-85 years female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception female: negative serum pregnancy test subjects who satisfy ARA (American Rheumatism Association) subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1> 1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria Exclusion Criteria: women who are breast-feeding or pregnant a history of xanthinuria allopurinol intolerance receiving thiazide diuretic therapy secondary hyperuricemia required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed. concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day). any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited. concomitant therapy with any urate-lowering therapy active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN subject was unable to take colchicine or contradictory to colchicine a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy rheumatoid arthritis or any active arthritis requiring for the medication treatment a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit participated in another investigational trial within the 30days prior to the screening visit any other significant medical condition as defined by the investigator

12. IPD Sharing Statement

Learn more about this trial

Phase III Trial of Febuxostat in Korea Gout Patients

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