This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Phase III Trial of Febuxostat in Korea Gout Patients

This study has been completed.
Information provided by:
SK Chemicals Co.,Ltd. Identifier:
First received: January 12, 2009
Last updated: NA
Last verified: October 2007
History: No changes posted
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

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
Active Comparator: 1 Febuxostat 40mg Drug: Febuxostat
Active Comparator: 2 Febuxostat 80mg Drug: Febuxostat
Active Comparator: 3 Febuxostat 120mg Drug: Febuxostat
Sham Comparator: 4 Allopurinol 300mg Drug: Febuxostat
Placebo Comparator: 5 Placebo 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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT00821392     History of Changes
Other Study ID Numbers: TMX-67
Study First Received: January 12, 2009
Last Updated: January 12, 2009

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs processed this record on July 21, 2017