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

Sponsor

Getz Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT02600780

Collaborator

(none)

Enrollment

Location

Arms

15.9

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: Febuxostat Drug: Allopurinol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allopurinol Allopurinol 300mg Tablets once daily for 90 days	Drug: Allopurinol Comparison of two anti-hyperuricemic molecules
Experimental: Febuxostat Febuxostat 40mg Tablets once daily for 90 days	Drug: Febuxostat Comparison of two anti-hyperuricemic molecules Other Names: Zurig

Arm

Intervention/Treatment

Active Comparator: Allopurinol

Allopurinol 300mg Tablets once daily for 90 days

Drug: Allopurinol

Comparison of two anti-hyperuricemic molecules

Experimental: Febuxostat

Febuxostat 40mg Tablets once daily for 90 days

Drug: Febuxostat

Comparison of two anti-hyperuricemic molecules

Other Names:

Zurig

Outcome Measures

Primary Outcome Measures

Serum uric acid levels [3 months]
To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months

Secondary Outcome Measures

Safety Assessment: number of participant with adverse events [At week 2, week 4 and week 12]
To determine the number of patients treated with Febuxostat once daily with Allopurinol once daily who experience any adverse drug reaction. All ADR are reported as per patient information leaflet

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both genders from 18 to 75 years of age
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.
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.
Patient willingly provides written informed consent

Exclusion Criteria:

History of significant concomitant illness
Active liver disease (SGPT> 1.5 times the upper limit of normal range)
Severe renal impairment (Serum Creatinine level >2mg/dl)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator
Cardiac disease or stroke (current or previous history)
Has a known history of infection with hepatitis B, hepatitis C, or HIV
Has a history of cancer within 5 years prior to the first dose of study medication
Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation