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

Hyperuricemia Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109121
• Other study ID #: A3007GT
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2010
• Last updated: January 5, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Nuon Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout
• Hyperuricemia
• Moderate to Severe Gout

Intervention

Drug:
• Combination 400
Tranilast 300 mg QD; Allopurinol 400 mg QD
• Allopurinol
Allopurinol 400 mg, QD
• Combination 600
Tranilast, 300 mg QD; Allopurinol 600 mg QD

Locations

Country	Name	City	State
United States	Nuon Investigative Site	Baltimore	Maryland
United States	Nuon Investigative Site	Billings	Montana
United States	Nuon Investigative Site	Bloomington	Indiana
United States	Nuon Investigative Site	Boise	Idaho
United States	Nuon Investigative Site	Charleston	South Carolina
United States	Nuon Investigative Site	Cincinnati	Ohio
United States	Nuon Investigative Site	Duncansville	Pennsylvania
United States	Nuon Investigative Site	Durham	North Carolina
United States	Nuon Investigative Site	Greenville	South Carolina
United States	Nuon Investigative Site	Honolulu	Hawaii
United States	Nuon Investigative Site	La Jolla	California
United States	Nuon Investigative Site	Lake Oswego	Oregon
United States	Nuon Investigative Site	New Port Richey	Florida
United States	Nuon Investigative Site	Oklahoma City	Oklahoma
United States	Nuon Investigative Site	Omaha	Nebraska
United States	Nuon Investigative Site	Owensboro	Kentucky
United States	Nuon Investigative Site	Reno	Nevada
United States	Nuon Investigative Site	Santa Maria	California
United States	Nuon Investigative Site	Spokane	Washington
United States	Nuon Investigative Site	Teaneck	New Jersey
United States	Nuon Investigative Site	Waco	Texas
United States	Nuon Investigative Site	Washington	District of Columbia
United States	Nuon Investigative Site	West Reading	Pennsylvania
United States	Nuon Investigative Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Nuon Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in serum uric acid (sUA) levels		4 weeks	No
Secondary	Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing		4 weeks	No