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

Inclusion Criteria6

Subjects are capable of giving informed consent
All male or female adult patients between 18 to 65 years age
All male or female adult patients's Serum Creatinine should be= or > 2 mg/dl
All patients with Asymptomatic = or > 8 mg/dl of Serum Uric Acid
All patients with Symptomatic = or > 6.5 mg/dl of Serum Uric Acid
Physician is the final authority to consider the patient, who is eligible for the clinical trial.

Exclusion Criteria5

Known history of allergic with Febuxostat or Allopurinol
Patient with Ischaemic cardiac disease
Acute gout
Renal dysfunction (Serum Creatinine = 4 mg/dL)
Hepatic dysfunction

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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."