Health Condition 1: null- Hyperuricemia with Gout
Conditions
Interventions
Intervention1: IN-PHRM-001: 80mg once daily for 8 weeks (addition of extra 40 mg dose after 4 weeks if target serum uric acid level not achieved)
Control Intervention1: Allopurinol: 300 mg once daily
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients of either sex between 18 and 80 years of age diagnosed with hyperuricemia (Serum uric acid greater or equal to 7 mg/dL) and gout by ARA Criteria
Exclusion criteria
Exclusion criteria: (1) Impaired hepatic or renal function (2) History of Serious cardiovascular disease (3) Pregnancy or lactation (4) Ongoing therapy with any prohibited medication or allopurinol >300mg/d (5) History of xanthinuria or active liver disease (6) History of alcohol abuse (7) Secondary hyperuricaemic conditions (8) Contraindication to colchicines (9) Participated in another investigational trial within 30 days prior to screening visit (10) History of known hypersensitivity to febuxostat, allopurinol, colchicine or any components in their formulation. (11) History of cancer within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients whose serum uric acid levels are 5.0 mg/dL.Timepoint: At the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percent reduction in serum uric acid level (2) Proportion of subjects requiring treatment for a gout flare Timepoint: (1) At every 2 weeks compared to baseline (2) During the last two visits of treatment | — |
Countries
India
Contacts
Public ContactDr Kanhei Charan Sahoo
Medical Advisor
Outcome results
None listed