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Completed

NCT Number: NCT01109121

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

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.

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Key information

Conditions

Moderate to Severe Gout Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nuon Investigative Site, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination 400

Drug

Tranilast 300 mg QD; Allopurinol 400 mg QD

Allopurinol

Drug

Allopurinol 400 mg, QD

Combination 600

Drug

Tranilast, 300 mg QD; Allopurinol 600 mg QD

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Nuon Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 22, 2010
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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