Phase III Trial of Febuxostat in Korea Gout Patients

January 12, 2009 updated by: SK Chemicals Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMX-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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