Zurig (Febuxostat) 40mg Efficacy and Safety Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02600780
• Date of registration: 02/11/2015
• Prospective Registration: No
• Primary sponsor: Getz Pharma
• Public title: Zurig (Febuxostat) 40mg Efficacy and Safety Trial ZEST
• Scientific title: Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout
• Date of first enrolment: November 2013
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02600780
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Pakistan

Contacts

• Name: Khalid Mahmood, FCPS
• Affiliation: Dow University of Health Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperuricemia

Intervention(s)

Drug: Febuxostat

Drug: Allopurinol

Primary Outcome(s)

Serum uric acid levels [Time Frame: 3 months]

Secondary Outcome(s)

Safety Assessment: number of participant with adverse events [Time Frame: At week 2, week 4 and week 12]

Secondary ID(s)

DUHS-GTZ-MD-001-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors