A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

Nuon Therapeutics, Inc.1 site in 1 country112 target enrollmentJune 2010

ConditionsModerate to Severe Gout Hyperuricemia

InterventionsAllopurinol Combination 400 Combination 600

DrugsCombination 400 Allopurinol Combination 600

Overview

Phase: Phase 2
Intervention: Allopurinol
Conditions: Moderate to Severe Gout
Sponsor: Nuon Therapeutics, Inc.
Enrollment: 112
Locations: 1
Primary Endpoint: Percent change from baseline in serum uric acid (sUA) levels
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nuon Therapeutics, Inc.

Eligibility 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