A clinical trial to study the effect of two drugs, febuxostat and allopurinol in chronic management of hyperuricemia in patients with gout.

Evaluation of efficacy and safety of febuxostat versus allopurinol in chronic management of hyperuricemia in patients with gout: a randomized, open label, comparative, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000611

Enrollment

200

Registered

2009-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Febuxostat tablet 40mg: Febuxostat 40 mg (1 tablet) once daily. For patients who do not achieve a serum uric acid less than 6 mg/dl after 2 weeks with 40 mg, febuxostat 80 mg (2 tablet

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients aged between 18 and 65 years. 2.Patients with gout and with serum urate concentration of at least 8.0 mg/dl. 3.Patient willing to give their informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2.Patients treated with azathioprine, mercaptopurine, and theophylline. 3.Patients being on cytotoxic chemotherapy. 4.Patients who are hypersensitive to Febuxostat or Allopurinol. 5.Patients with hypertension or cardiac insufficiency.

Design outcomes

Primary

Measure	Time frame
1-Evaluation of percentage of patients with serum urate concentration < 6mg/dlTimepoint: 0,2,8,12 weeks	—

Secondary

Measure	Time frame
1-Evaluation of percentage reduction in serum urate concentration from baseline. 2-Evaluation of Change in frequency of gout flares. 3-Global evaluation by investigator and patient. Timepoint: 1- 2,8,12 weeks 2- 0,2,8,12 weeks 3- 12 week	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results