RecruitingPhase 4ACTRN12612000434897

To compare the efficacy & safety profile of Febuxostat with Allopurinol in local Pakistani hyperuricemic patients.

Compare the Urate lowering response of Febuxostat & Allopurinol in Hyperuricemic patients

Sponsor

PharmEvo (Pvt.) Ltd.

Enrollment

120 participants

Start Date

Apr 1, 2012

Study Type

Interventional

Conditions

Gout Hyperuricemia

Summary

Study Summary Title To compare the efficacy & safety profile of Febuxostat with Allopurinol in local Pakistani hyperuricemic patients. Protocol Number GOURIC-OS-01 Phase: Phase-IV Study Methodology: Open label, Multicenter, Randomized, Parallel group Phase-IV Study Study Duration: 12 Months Study Center(s): Ziauddin University Hospital, Medilink Hospital, JMCH Karachi & North West HospitalPeshawar. Primary Objective: Compare the Urate lowering response of Febuxostat & Allopurinol in Hyperurecemic patients Secondary Objective: Compare the Drug Tolerability with the treatment of Febuxostat verses Allopurinol in Hyperurecemic patients Number of Subjects: 60 patients on Febuxostat and 60 patients on Allopurinol, Total number of subjects = 120 Diagnosis and Main Inclusion Criteria: All Symptamatic & Asymptamatic patients with = or >8mg/DL of Uric Acid and age should be 18 to 65 years Study Product, Dose, Route, Regimen: Febuxostat 40-80 mg Tab Once daily (O.D.) oral or Allopurinol 100-300 mg tablet once daily (O.D.) or as per physician advice. Duration of Drug administration in study: 6 months Statistical Methodology: T- Independent Test

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two medications used to lower uric acid levels in the blood. High uric acid can cause gout and joint damage. The two drugs being compared are febuxostat and allopurinol, both of which block the production of uric acid. Researchers want to find out which drug works better and which has fewer side effects in Pakistani patients with high uric acid levels. You may be eligible if: - You are between 18 and 65 years old - You have high uric acid levels (8 mg/dL or above without symptoms, or 6.5 mg/dL or above with symptoms) - Your kidney function is within an acceptable range (creatinine at or above 2 mg/dL) - You are able to give informed consent You may NOT be eligible if: - You have a known allergy to febuxostat or allopurinol - You have ischemic heart disease - You currently have an acute gout attack - You have severe kidney dysfunction (creatinine at or above 4 mg/dL) - You have liver disease Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Febuxostat 40-80 mg Tab Once daily (O.D.) oral, for 6 months "The recommended starting dosage is 40 mg once daily. After two weeks, your healthcare provider should check your uric acid level (using

Febuxostat 40-80 mg Tab Once daily (O.D.) oral, for 6 months "The recommended starting dosage is 40 mg once daily. After two weeks, your healthcare provider should check your uric acid level (using a blood test). If your level is not sufficiently low (6 mg/dL or less), the dosage may be increased to 80 mg once daily."