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

July 30, 2019 updated by: Getz Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74900
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum uric acid levels
Time Frame: 3 months
To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment: number of participant with adverse events
Time Frame: 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
At week 2, week 4 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Investigators

  • Principal Investigator: Khalid Mahmood, FCPS, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUHS-GTZ-MD-001-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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