Allopurinol Outcome Study

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Allopurinol

Criteria

Inclusion Criteria:

• Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.

• Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.

• If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.

• Must have had at least 2 gout flares in the past year.

Exclusion Criteria:

• Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

• History or suspicion of drug abuse.

• History of autoimmune disease requiring systemic treatment.

• Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.

• History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).

• Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.

• Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).

• Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.

• Kidney or other organ transplant.

• Active peptic ulcer disease requiring treatment.

• History of xanthinuria, active liver disease, or hepatic dysfunction.

• If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).

• Known hypersensitivity or allergy to allopurinol.