A clinical trial to study the effect of two drugs, febuxostat and allopurinol in chronic management of hyperuricemia in patients with gout.
Phase 3
Completed
- Registration Number
- CTRI/2009/091/000611
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-Evaluation of percentage of patients with serum urate concentration < 6mg/dlTimepoint: 0,2,8,12 weeks
- Secondary Outcome Measures
Name Time Method 1-Evaluation of percentage reduction in serum urate concentration from baseline.<br>2-Evaluation of Change in frequency of gout flares.<br>3-Global evaluation by investigator and patient.<br>Timepoint: 1- 2,8,12 weeks<br>2- 0,2,8,12 weeks<br>3- 12 week