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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600780
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

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 Name: Zurig




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600780


Locations
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Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 74900
Sponsors and Collaborators
Getz Pharma
Investigators
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Principal Investigator: Khalid Mahmood, FCPS Dow University of Health Sciences

Publications of Results:
Other Publications:
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Responsible Party: Getz Pharma
ClinicalTrials.gov Identifier: NCT02600780    
Other Study ID Numbers: DUHS-GTZ-MD-001-13
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Keywords provided by Getz Pharma:
Febuxostat
Efficacy
Safety
Allopurinol
Hyperuricemia
Zurig
Getz Pharma
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs