Zurig (Febuxostat) 40mg Efficacy and Safety Trial (ZEST)

Getz Pharma

Status and phase: Completed; Phase 4

Conditions: Hyperuricemia

Treatments: Drug: Febuxostat; Drug: Allopurinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600780

DUHS-GTZ-MD-001-13

Details and patient eligibility

About

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.

Full description

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 recorded all the data of visits in CRF which was analyzed through SPSS version 20.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Allopurinol

Active Comparator group

Description:

Allopurinol 300mg Tablets once daily for 90 days

Treatment:

Drug: Allopurinol

Febuxostat

Experimental group

Description:

Febuxostat 40mg Tablets once daily for 90 days

Treatment:

Drug: Febuxostat