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

Nuon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Moderate to Severe Gout

Treatments: Drug: Allopurinol; Drug: Combination 400; Drug: Combination 600

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109121

A3007GT

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 3 patient groups

Allopurinol

Active Comparator group

Description:

Allopurinol

Treatment:

Drug: Allopurinol

Combination 400

Experimental group

Description:

Tranilast and Allopurinol

Treatment:

Drug: Combination 400

Combination 600

Experimental group

Description:

Tranilast and Allopurinol

Treatment:

Drug: Combination 600