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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000434897

Acronym

FASE

Enrollment

120

Registered

2012-04-17

Start date

2012-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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."

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results