Clinical trial NCT01109121: Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Gout
Hyperuricemia
Keywords: Moderate to severe gout
Hyperuricemia
Lead sponsor: Nuon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline in serum uric acid (sUA) levels
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing
timeFrame: 4 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Nuon Investigative Site
state: California
city: Santa Maria
country: United States
facility: Nuon Investigative Site
state: California
city: Washington
country: United States
facility: Nuon Investigative Site
state: District of Columbia
city: New Port Richey
country: United States
facility: Nuon Investigative Site
state: Florida
city: Honolulu
country: United States
facility: Nuon Investigative Site
state: Hawaii
city: Boise
country: United States
facility: Nuon Investigative Site
state: Idaho
city: Bloomington
country: United States
facility: Nuon Investigative Site
state: Indiana
city: Owensboro
country: United States
facility: Nuon Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: Nuon Investigative Site
state: Maryland
city: Wheaton
country: United States
facility: Nuon Investigative Site
state: Maryland
city: Billings
country: United States
facility: Nuon Investigative Site
state: Montana
city: Omaha
country: United States
facility: Nuon Investigative Site
state: Nebraska
city: Reno
country: United States
facility: Nuon Investigative Site
state: Nevada
city: Teaneck
country: United States
facility: Nuon Investigative Site
state: New Jersey
city: Durham
country: United States
facility: Nuon Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Nuon Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Nuon Investigative Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Nuon Investigative Site
state: Oregon
city: Duncansville
country: United States
facility: Nuon Investigative Site
state: Pennsylvania
city: West Reading
country: United States
facility: Nuon Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Nuon Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Nuon Investigative Site
state: South Carolina
city: Waco
country: United States
facility: Nuon Investigative Site
state: Texas
city: Spokane
country: United States
facility: Nuon Investigative Site
state: Washington
Study officials:
affiliation: Nuon Therapeutics, Inc.
name: Director, Nuon Clinical Trials Group
role: STUDY_DIRECTOR
References: