Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Launched by GETZ PHARMA · Nov 6, 2015

Keywords

ClinConnect Summary

Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily for 3 months period.

Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other complications were monitored at screening and as per eligibility criteria 50 patients were enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during and at the end of treatment. The safety profile has also been monitored during the treatment period. Investigator collected and r...

Gender

ALL

Eligibility 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