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Phase III Trial of Febuxostat in Korea Gout Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00821392
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Information provided by:
SK Chemicals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date January 13, 2009
Study Start Date  ICMJE August 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase III Trial of Febuxostat in Korea Gout Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE Drug: Febuxostat
Study Arms  ICMJE
  • Active Comparator: 1 Febuxostat 40mg
    Intervention: Drug: Febuxostat
  • Active Comparator: 2 Febuxostat 80mg
    Intervention: Drug: Febuxostat
  • Active Comparator: 3 Febuxostat 120mg
    Intervention: Drug: Febuxostat
  • Sham Comparator: 4 Allopurinol 300mg
    Intervention: Drug: Febuxostat
  • Placebo Comparator: 5 Placebo
    Intervention: Drug: Febuxostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January¬†12,¬†2009)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

<Day -14>

  1. age :18-85 years
  2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
  3. female: negative serum pregnancy test
  4. subjects who satisfy ARA (American Rheumatism Association)
  5. 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:

  1. women who are breast-feeding or pregnant
  2. a history of xanthinuria
  3. allopurinol intolerance
  4. receiving thiazide diuretic therapy
  5. secondary hyperuricemia
  6. required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
  7. 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).
  8. any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
  9. alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
  10. concomitant therapy with any urate-lowering therapy
  11. active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
  12. subject was unable to take colchicine or contradictory to colchicine
  13. a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy
  14. rheumatoid arthritis or any active arthritis requiring for the medication treatment
  15. 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
  16. participated in another investigational trial within the 30days prior to the screening visit
  17. any other significant medical condition as defined by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00821392
Other Study ID Numbers  ICMJE TMX-67
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SK Chemicals Co.,Ltd.
Study Sponsor  ICMJE SK Chemicals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SK Chemicals Co., Ltd.
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP