Zurig (Febuxostat) 40mg Efficacy and Safety Trial

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.

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

Details

• Lead Sponsor: Getz Pharma
• Treatments: Allopurinol; Febuxostat

Criteria

Inclusion Criteria:

1. Both genders from 18 to 75 years of age

2. Must have a serum urate level ≥ 6.8 milligram per deciliter (mg/dL) and/or subjects recruited with Gout; must meet American College of Rheumatology criteria for Gout.

3. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

4. Patient willingly provides written informed consent

Exclusion Criteria:

1. History of significant concomitant illness

2. Active liver disease (SGPT> 1.5 times the upper limit of normal range)

3. Severe renal impairment (Serum Creatinine level >2mg/dl)

4. Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator

5. Cardiac disease or stroke (current or previous history)

6. Has a known history of infection with hepatitis B, hepatitis C, or HIV

7. Has a history of cancer within 5 years prior to the first dose of study medication

8. Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation