PHASE III CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-PHRM-001 IN COMPARISON WITH ALLOPURINOL IN ADULT PATIENTS WITH GOUT.

Phase 3

• Conditions: Health Condition 1: null- Hyperuricemia with Gout

• Registration Number: CTRI/2009/091/001087
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 270

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients whose serum uric acid levels are 5.0 mg/dL.Timepoint: At the end of treatment

Secondary Outcome Measures

Name	Time	Method
(1) Percent reduction in serum uric acid level <br/ ><br>(2) Proportion of subjects requiring treatment for a gout flare <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: (1) At every 2 weeks compared to baseline <br/ ><br>(2) During the last two visits of treatment <br/ ><br>