CTRI/2009/091/001087OtherPhase 3
AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-PHRM-001 IN COMPARISON WITH ALLOPURINOL IN ADULT PATIENTS WITH GOUT
Trial Snapshot
- Phase
- Phase 3
- Status
- Other
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •(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
Investigators
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