Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nuon Therapeutics, Inc.
• Treatments: Allopurinol; Tranilast

Criteria

Inclusion Criteria:

• Male or female, aged 18 to 80

• Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis

• Hyperuricemia with a sUA ≥8.0 mg/dL

Exclusion Criteria:

• Pregnant or nursing

• Known hypersensitivity to any of the components of tranilast or allopurinol

• Known history of xanthinuria or kidney stones

• Use of an investigational drug within 30 days

• Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin

• Subject is planning or likely to require a surgical procedure during the study