Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase III Trial of Febuxostat in Korea Gout Patients
This study has been completed.
Sponsored by: SK Chemicals Co.,Ltd.
Information provided by: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00821392
  Purpose

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


Condition Intervention Phase
Gout
Drug: Febuxostat
Phase III

MedlinePlus related topics: Gout
Drug Information available for: Allopurinol Allopurinol sodium Tei 6720
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by SK Chemicals Co.,Ltd.:

Enrollment: 181
Study Start Date: August 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Febuxostat 40mg: Active Comparator Drug: Febuxostat
2 Febuxostat 80mg: Active Comparator Drug: Febuxostat
3 Febuxostat 120mg: Active Comparator Drug: Febuxostat
4 Allopurinol 300mg: Sham Comparator Drug: Febuxostat
5 Placebo: Placebo Comparator Drug: Febuxostat

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: SK Chemicals Co.,Ltd. ( SK Chemicals Co.,Ltd. )
Study ID Numbers: TMX-67
Study First Received: January 12, 2009
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00821392  
Health Authority: Korea: Food and Drug Administration

Study placed in the following topic categories:
Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis
Febuxostat
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

Additional relevant MeSH terms:
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009