Phase III Trial of Febuxostat in Korea Gout Patients

This study has been completed.
Sponsor:
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00821392
First received: January 12, 2009
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

  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
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

No publications provided

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

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014