Trial Information

Do You Suffer From Gout?

Researchers wish to further assess the long term safety of an approved urate-lowering therapy (ULT) known as Febuxostat. This medication will be compared to another commonly used, approved ULT called Allopurinol over a study period of approximately 5 years. Both drugs are considered study drugs for the purpose of this research.

Summary: We are looking for volunteers who live in the Denver area who have been diagnosed with gout and have a history of heart disease to take part in this pharmaceutical sponsored clinical research study at our office in Wheat Ridge, Colorado. Volunteers must be at least 50 years old for males and 55 for females and postmenopausal, and in general good health.

Medication under Study: Febuxostat 40 mg daily or Allopurinol 200 mg or 300 mg daily based on baseline kidney function and stable thiazide diuretic use. Febuxostat will increase to 80 mg daily at Month 1 of treatment if the target uric acid level is not reached. All subjects will receive gout flare prophylaxis for the first 6 months of study medication treatment.

Study Information:

There are approximately 10 study visits in the first year, including a screening visit.
Study procedures include study related physical exams, lab tests and ECGs.
Compensation for study related time and/or travel is available to qualified study participants.
There is no charge for participation.

Principal Investigator: William Elzi, M.D. of Wheat Ridge Internal Medicine in Wheat Ridge, Colorado

Inclusion Criteria (Partial List)

Males at least 50 years old and females at least 55 years old
Study volunteers must have gout and a history of heart disease
Females must be postmenopausal or without menstruation for at least 2 years
Willing to discontinue current gout medication, if any, for up to 2 weeks during the screening period of the study

More entry criteria will be assessed with a telephone screen and at study visits.

Exclusion Criteria (Partial List)

Hyperuricemia due to another cause such as organ transplant
Active peptic ulcer disease
Heart attack or stroke within the past 2 months

More entry criteria will be assessed with a telephone screen and at study visits.

Jodi Frazier, Mary Reid or Cheri Casey, Study Coordinators
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Phone: 303-940-0909
Fax: 303-940-0308
Email: research@wscrinc.com

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Research Center Information: Western States Clinical Research, Inc.

If you would like to learn more about participating in this study, please send an email message using the form below.

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