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. |
ClinicalTrials.gov Identifier: NCT00821392 |
Recruitment Status :
Completed
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gout | Drug: Febuxostat | Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
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 |

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | SK Chemicals Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00821392 |
Other Study ID Numbers: |
TMX-67 |
First Posted: | January 13, 2009 Key Record Dates |
Last Update Posted: | January 13, 2009 |
Last Verified: | October 2007 |
Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Febuxostat Gout Suppressants Antirheumatic Agents |