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

Nuon Therapeutics, Inc.112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Moderate to Severe Gout Hyperuricemia

Interventions

Combination 400DRUG

Tranilast 300 mg QD; Allopurinol 400 mg QD

AllopurinolDRUG

Allopurinol 400 mg, QD

Combination 600DRUG

Tranilast, 300 mg QD; Allopurinol 600 mg QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (24)

Nuon Investigative Site

La Jolla, California, United States

Outcomes

Primary Outcomes

Percent change from baseline in serum uric acid (sUA) levels

Time frame: 4 weeks

Secondary Outcomes

Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing

Time frame: 4 weeks

Data from ClinicalTrials.gov

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