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Phase III Trial of Febuxostat in Korea Gout Patients

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00821392
Collaborator
(none)
181
Enrollment
5
Arms
13
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
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 :
Aug 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • SK Chemicals Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00821392
    Other Study ID Numbers:
    • TMX-67
    First Posted:
    Jan 13, 2009
    Last Update Posted:
    Jan 13, 2009
    Last Verified:
    Oct 1, 2007
    Additional relevant MeSH terms:
    Gout
    Febuxostat

    Study Results

    No Results Posted as of Jan 13, 2009