Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Phase 4

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Allopurinol; Drug: Febuxostat

• Registration Number: NCT02600780
• Lead Sponsor: Getz Pharma

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.

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol	Allopurinol	Allopurinol 300mg Tablets once daily for 90 days
Febuxostat	Febuxostat	Febuxostat 40mg Tablets once daily for 90 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan