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

Phase 2

Completed

• Conditions: Moderate to Severe Gout; Hyperuricemia
• Interventions: Drug: Combination 400; Drug: Combination 600; Drug: Allopurinol

• Registration Number: NCT01109121
• Lead Sponsor: Nuon Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-06
• Primary Completion: 2010-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination 400	Combination 400	Tranilast and Allopurinol
Combination 600	Combination 600	Tranilast and Allopurinol
Allopurinol	Allopurinol	Allopurinol

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in serum uric acid (sUA) levels	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nuon Investigative Site; 🇺🇸 Spokane, Washington, United States